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Defines and implements procedures and processes to assure that Hovione facilities, equipment and supporting systems are fit for purpose and comply with applicable quality standards, documenting evidence that these can perform effectively and reproducibly to meet predetermined specifications and quality attributes to manufacture a product when operated within established parameters. Works collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation application, by developing and deploying Best Practices.   - Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH)  - Participate in project teams that require expertise in Computerized Systems - Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality  - Implement the defined policies for Computerized Systems life cycle Management  - Perform validation activities of the Computerized System projects and provide the necessary guidance to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle  - Implement data integrity principles during the Computerized System life cycle, as defined - Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Analytical equipment, Manufacturing equipment, DCS, PLC and other stand-alone software  - Issue, review and approve protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Qualification of Computerized Systems and other validation/qualification documents  - Review/approve/close corporate Computerized System change controls, deviations, incidents submitted by any Department/Site, to ensure that the system is maintained in an accurate, validated, and compliant state - Review/approve documentation regarding Computerized Systems data integrity and its life cycle management  - Provide training and coaching in quality culture and data integrity principles regarding Computerized Systems  - Support internal, external/ customers’ audits and health authorities’ inspections  - Perform assigned tasks as planned and deliver on time, safely, efficiently, reliably and in a cost-effective manner  - Propose improvements to the area as appropriate and solve problems  - Make quality and timely decisions within the Quality’s Computerized Systems tasks under his / her responsibility  - Gather relevant data to inform the decision makers regarding complex issues  - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Key roles for this person would be to help with more operational aspects: - Update media toolkits and media database for trade publications, liaise for booking of advertising, material availability etc - Identify and liaise with trade fairs/suppliers for implementation of booths, preparation of contracts - Scheduling of photo sessions and filming for campaigns - Identification of short list of suppliers - Preparation of sales materials for trade fairs, along with feedback collection via surveys and respective analysis

Leading the team of Strategic Alliances as line manager reporting to the VP Business Transformation & Licensing Develop and nurture a network of contacts in order to establish strategic partnerships with Universities, startup companies, business associations, and other relevant market or scientific players in areas defined as strategic for Hovione. Manage the network in a comprehensive business development database Identify internal challenges and unmet needs and find new solutions and new partners to solve problems and improve products and/or processes. Identify, through the network of contacts, external solutions that may resolve internal needs or answer to unmet market needs that may become opportunities for Hovione Perform preliminary evaluation of the potential partners and/or solutions based on defined processes and criteria. Attend international meetings and conferences scouting for opportunities and presenting Hovione’s strengths and objectives as a partner   Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead partnering project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Optimizing partner satisfaction and securing long-term successful partnerships are central to the function.     - Organize the projects and partnerships under responsibility in accordance with the mission and goals of Hovione, giving direction to project managers and supporting the resolution of complex issues, guaranteeing projects are delivered according to the assigned criteria (output, budget and timings) - Propose new partnering projects and elaborate preliminary budgets, teams, activity plan and deadlines - Propose and control long-term goals for the partnerships under responsibility, guaranteeing that partnerships follow a path in the appropriate direction - Apply an evaluation method for the partnerships under responsibility to assess the partnerships’ successfulness and identify areas for improvement, analyzing risks and controlling KPIs - Act as a facilitator of partnership projects, joining stakeholders and communicating key aspects of the partnerships - Produce complex partnership status and KPIs reports and present it as requested - Participate in strategic forums to discuss the future direction of Hovione’s collaborations and projects, contributing with analysis and insights - Manage the TMs assigned to his/her/its area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity - Develop and propose for approval the short and mid-term goals, annual budget and budget plan for the partnerships and projects under responsibility in line with the corporate strategy, in order to align activities with Hovione strategic objectives - Prepare and propose for superior approval the annual budget of partnerships and projects under responsibility, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/her/its TMs - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.   - Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready” - Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities - Act as a catalyst for change and improvement in performance/quality - Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR - Provide an example of professionalism and support the induction and training of new colleagues within the area - Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured - Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports - To prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary. - Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits - Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate - To close open deviations and propose CAPAs based on the outcome of periodic follow-ups - Prepares SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate - Approves IOPs, process master documentation and product specifications as required and appropriate. - Ensures that SOPs and IOPs are up to date, compliant and supports efficient production - Review regulatory documentation and co-ordination of site documentation to support regulatory requirements - Authorize the usage of production equipment/utilities when qualification required - Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required - Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate - To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates - To maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required - To approve Validation Master Plans, Process Validation Protocols and reports as required - Accurately use and maintain all information systems - Support the generation / reporting of KPIs for the team. - Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area - Co-ordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes - To provide relevant training to new colleagues, and to the other areas in applicable cGMP, internal procedures and quality systems in accordance with established training plans - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the Quality Assurance tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Key roles for this person: - Perform audit trail review of analytical softwares, as per defined procedures - Develop and validate formulas in analytical softwares to allow for automatic calculations

Key roles for this person: - Evaluate monographs available in EP, USP, Chinese and JP Pharmacopeias - Check conformance of Hovione methods and procedures with the monographs - Participate in the evaluation of the risks of non compliance - Participate in the definition of the correction/mitigation strategies - Preparation of the materials to be used in this process

- Apply strategic-thinking and forward planning to the area projects and implement the necessary actions to promote faultless execution - Assure the adequate planning of area activities in line with clients and internal requirements and ensuring the liaison with relevant third parties - Ensure that all projects are staffed appropriately and that the materials requirements of the area are met to guarantee all area’s responsibilities are met and the group is able to exceed customers’ expectations - Ensure the information flow between all R&D areas and other relevant stakeholders - Ensure scientific development activities occur with the right level of guidance and technical know-how - Propose new technologies and methodologies and the necessary investments and resources taking in account both specific driven project objectives and the group scientific and technical objectives and support in their implementation - Review and approve the protocols, reports and documentation prepared in the Area - Ensure the continuous improvement and subsequent implementation of new methodologies that can efficiently support process development - Promote scientific activities (e. seminars, congress participations, innovation ideas, papers and publications) and innovation within the team and encourage the sharing of knowledge with other teams - Be part of problem-solving processes as required by the team - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives - Monitor area´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Dedicated function focused on the development and implementation of the strategic plans and supporting initiatives necessary to realize the Corporate commitment to Sustainability. This function plays a key role in driving the changes needed for a sustainable future and acts to promote and monitor company performance in this area. Expected to have a high level of engagement with site and function leaders and promotes, motivates and supports an integrated company response on sustainability.   - Work with key internal stakeholders and/or external partners, driving alignment on sustainability project expectations. - Serve as the point of contact for external ESG stakeholders, providing effective communication to team members, cross-functional stakeholders, and other relevant parties. - Responsible for ESG client response & reporting including. program metrics and program benchmarks including annual reports and surveys. - Support the implementation and integration of ESG internal standards in all supplier touchpoints (i.e., Code of Conduct, RFPs, Contract Templates) - Work closely with business leaders to develop and embed ESG strategies into supply chain and ensures appropriate purchasing decisions are made with consideration of the ESG strategy. - Assist in the development of short & long-term ESG project plans, key deliverables, and milestones and provide support in working through project changes or roadblocks that need to be resolved - Support cross-functional teams in executing sustainability projects, monitoring and reporting on progress, and identifying necessary actions to achieve project goals. - Where appropriate, provide thought leadership on sustainability best practices to progress the Hovione ESG/Sustainability agenda and support the development of key initiatives - Provide support to monitor and evaluate external trends, including developing legislation and advocacy positions for insights to inform ongoing ESG strategy and practices. - Role may support the completion of external sustainability reporting activities, social responsibility surveys and other aspects related to sustainable procurement

• Ensures master data integrity as well as maintaining the processes to support the data quality. • Assure quality of master data development and documentation of processes with other functional data owners to support ongoing maintenance. • Identifies areas for data quality improvements and helps to resolve data quality problems through the appropriate root cause analysis, process control the respective enhancement. • Assists in data management, governance, and data quality of master data requirements with other functional data owners to ensure functional master data integrity. • Provide support in the application and implementation procedures of data standards and guidelines on data ownership to ensure access to and integrity of data sets. • Conducts data cleaning to rid the system of old, unused data, or duplicate data for better management and quicker access. • Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update. • Monitor performance and apply action plans to improve result of KPI's related to BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy • Create periodically reports detailing the status of critical activities of on-going projects and KPIs. • Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner. • Propose improvements to the area as appropriate and solve problems. • Make quality and timely decisions within the operations planning and data management tasks under her / his responsibility • Gather relevant data to inform the decision makers regarding complex issues • Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)

       Our Operational Excellence Specialist role will require on-site presence, at our East Windsor, NJ facility.   Delivers excellence in end-to-end process improvement practices, methodologies and behaviours to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviours and enable alignment of priorities across areas. Supports the continuous improvement cycle aiming at the sustainable increase of unitary output (effective throughput per resource unit used). Responsible for developing, deploying and maintaining the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviours to enable engagement; as well as for deriving metrics to measure plant and equipment capacity to support identification of equipment and process flow bottlenecks, contributing to improved layouts whilst assuring compliance with established guidelines.   - Implement productivity actions and define priorities within own work to achieve the proposed goals (efficiency, efficacy and cost consistency) - Drive, manage and train the teams that will take part on Continuous Improvement Initiatives, problem solving and risk assessment groups - Coach operational teams in their daily communication meetings, ensuring that defined methods are properly used in all areas - Support the development of Operational Excellence Training Program and run training sessions - Update the productivity indicators of the plant - Support a Continuous Improvement process in the plant that is visible for all, through indicators, working methods, visual management, etc. - Ensure the constant reduction of the time and costs required in all activities in Manufacturing - Ensure that all operational staff are trained according to Operational Excellence training procedures in place - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Promote one single source of truth, data highly reliable and up to date, best in class tools and practices to enhance productivity and the ability to manage costs. Facilitate cross-functional Sales and Operations Planning (S&OP, mid-term horizon) and Execution (short-term horizon) processes to create tensions and deliver best compromises in terms of supply response to demand forecast. Establish plans with appropriate granularity and firmness depending on horizons (mid, short-term horizons and execution), providing supply scenarios to demand, considering production and support areas capability and the best efficiency of resources' usage (people, equipment and materials), based on demonstrated performance.   - Create shift detailed schedule (30) / weekly plan (H90 & H700) for the whole portfolio to answer demand, having into account production and support areas constraints - Review and analyze the allocated resources (human resources, materials and/or processes) to comply with plan - Anticipate and monitor potential scheduling/planning and data management challenges, taking actions to mitigate risks; troubleshoots scheduling /planning / data problems; facilitates and actively contributes to H700H90 and H90H30 meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies - Optimize the plan, ensuring the existence of resources for the continuous production and maximizing efficiency - Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update; - Monitor performance and apply action plans to improve result of KPI's related to Planning/Scheduling process, mainly: Plan Adherence, Campaign Lead Time Adherence, Batch Execution Adherence, Batch Finish Date Adherence, Shift Performance, BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy - Create periodically reports detailing the status of critical activities of on-going projects and KPIs - Promote one single source of truth, data highly reliable and up to date, best in class tools and practices - Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the operations planning and data management tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)

Promote one single source of truth, data highly reliable and up to date, best in class tools and practices to enhance productivity and the ability to manage costs. Facilitate cross-functional Sales and Operations Planning (S&OP, mid-term horizon) and Execution (short-term horizon) processes to create tensions and deliver best compromises in terms of supply response to demand forecast. Establish plans with appropriate granularity and firmness depending on horizons (mid, short-term horizons and execution), providing supply scenarios to demand, considering production and support areas capability and the best efficiency of resources' usage (people, equipment and materials), based on demonstrated performance.   - Create shift detailed schedule (30) / weekly plan (H90 & H700) for the whole portfolio to answer demand, having into account production and support areas constraints - Review and analyze the allocated resources (human resources, materials and/or processes) to comply with plan - Anticipate and monitor potential scheduling/planning and data management challenges, taking actions to mitigate risks; troubleshoots scheduling /planning / data problems; facilitates and actively contributes to H700H90 and H90H30 meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies - Optimize the plan, ensuring the existence of resources for the continuous production and maximizing efficiency - Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update; - Monitor performance and apply action plans to improve result of KPI's related to Planning/Scheduling process, mainly: Plan Adherence, Campaign Lead Time Adherence, Batch Execution Adherence, Batch Finish Date Adherence, Shift Performance, BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy - Create periodically reports detailing the status of critical activities of on-going projects and KPIs - Promote one single source of truth, data highly reliable and up to date, best in class tools and practices - Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the operations planning and data management tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Fulfill and rigorously promote all applicable Good Manufacturing Practices (GMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities. - Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures. - Responsible for the accurately and timely preparation and review of manufacturing process documentation, including but not limited to batch production records, campaign reports, change controls, operating manuals / procedures, mass balance sheets, bill of materials, cost proposals, validation plans and validation reports and other GMP related documentation for all processes run in operations. - Execute and ensure, with autonomy, risk assessments for assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identified hazards are addressed prior to performing any operational activities. - Report, investigate and document any abnormal observations, potential risks, discrepancies, deviations and non-conformances in accordance with Hovione internal procedures. - Timely devise and implement effective and efficient corrective actions / preventive actions (CAPAs), as appropriate. - Participate in all necessary training as defined in the training plan. - Report abnormal situations at the installations, as soon as these are detected so that corrective maintenance is triggered in due time. - Identify the necessary corrective and preventive actions to keep, in a proactive manner, the installation in good conditions. - Act as the lead process engineer in multiple projects with limited support and liaises directly with customer project teams. - Updates the Line Manager and the team members on relevant occurrences and trends that may have a significant impact on Area KPIs. - Provide training on manufacturing processes, production systems and procedures to operational team members - Participate, as required, in the induction of new colleagues ensuring they are appropriately trained in accordance with established training plans. - Drive high standards in the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate for safe operating and high quality performance. - Support internal stakeholders on, including but not limited to, generation of 3P’s and answering queries on cost and cycle time associated with assigned processes (where applicable) - Assist with audits and investigations. - Support the generation / reporting of KPIs for the team and follow all annual performance review requirements, including completion of the self-assessment. - Contribute to the design of new facilities or to the modification of existing ones. - Engage in a supportive work environment that allows for open collaboration between team members to share technical knowledge. - Develop and accumulate strong engineering expertise, sharing knowledge of state-of-the-art technologies and methodologies within the area. - Initiate and prepare tech-transfers and process improvement projects for established and new processes utilizing best available technology, practices and tools. - Contributes to the increase of productivity by reviewing, proposing, planning and implementing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes. - Responsible for creating and reviewing cost proposals and project plans when implementing optimization projects. - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Performs maintenance on equipment and systems (e.g., mechanical, electrical). Evaluates and recommends equipment improvements to increase reliability, capability and yield. Performs equipment condition analysis (during preventive and unscheduled maintenance). Troubleshoots and diagnoses equipment problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures.   - Ensure the maintenance, service, repair and troubleshoot of all equipment and installations (mechanical / electrical / instrumentation) on site is performed as per Standard Operating Procedures, Maintenance work instructions or engineering best practices - Participate in risk assessment of work permits and control of their appropriate execution - Actively participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D) - Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA) - Assist in the training of more junior members of the maintenance area in their area of expertise - Ensure the correct completion of all required documentation, paper or system based, associated with own and area work - Ensure proper tidiness and cleanliness of the maintained equipment and area as well as of his/her working area - Ensure that area or his/her assign tolls are kept in good shape in what regards to their functionality and cleanliness - Collaborate in the analysis / investigation of irregularities or CAPAs pertaining to area - Ability to choose the appropriate methods or tools - Ability to provide training and support colleagues - Follow established procedures and processes, with the ability to interpret instructions, drawings and equipment technical documentation - Resolve non-complex problems related to discipline, with more complex issues being referred to line manager or technical team member. - Adapt to changing site priorities Support other team members in prioritizing work - Provide guidance and support to colleagues informally - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes - Ensure facility activities are carried out in compliance with all GMP, legal and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice - Undertake any additional tasks commensurate with the role as and when required.

Coordinates inbound and outbound logistical operations being accountable for the imports and exports of goods and also information flows supporting these operations. Manages inventory, warehousing operations, regulate warehouse space, including reception, pathway, sampling, dispensing and arrange shipments, and local transportation to ensure an efficient supply of goods. Administers an effective system that meets the organization’s inventory targets through efficient and transparent flow of information and materials, including raw materials, intermediates, finished products and spare parts.   - Oversee warehouse activities and TMs, ensuring all applicable procedures are implemented and making sure the assigned resources are selected, packaged, loaded and/or dispatched safely, timely and efficiency - Promote productivity and safety in warehouse activities, by planning activities and shifts of operators, anticipating needs and workloads - Monitor and control warehouse operations according to HSE practices, cGMP, cGDP compliance and quality policy - Assure visibility of monitoring results for internal stakeholders in a order to contribute for orchestration of the site operations - Review and control records of resources handled according to established processes - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks and suggesting process optimizations or improvements - Ensure that raw materials are tested and dispensed to production according to procedures - Ensure that inventories are made and recorded according to procedures, guaranteeing the identification of product losses and taking correcting actions - Guarantee that equipment is inspected and guarantee proper maintenance and replacement - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - Analyze warehouse data in order to optimize resources and procedures for continuous improvement - Support in the training of warehouse teams, mainly giving inputs for the elaboration of contents and training goals - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with Supply Chain strategic objectives - Monitor own budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs

Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and benchmarks to measure actual performance against goals on a regular basis. Promotes alignment by understanding and communicating business and customers’ needs and requirements through the organization.   - Lead sourcing and procurement activities for specific categories of indirect materials and services to ensure business alignment and guidance, compliance, stakeholder management (internal and external) and optimize categories' spend. - Develop appropriate purchasing strategies for specific categories of indirect materials and services to ensure continuity of supply, increased productivity, reduced costs, right quality levels and regulatory & legal compliance. Proactively seek and suggest improvement opportunities. - Develop Supplier’s relationships and trust and ensure the Company’s values are shared and aligned with Supplier’s values to establish long term relationships with key and strategic suppliers who share values and enable the company to outperform competition. - Provide the organization with important insights on business, market conditions and the competitive landscape aiming at leveraging the global and local markets and differentiated sourcing strategies. - Develop, right size and maintain a robust and sustainable supply base to achieve the procurement goals in terms of financial performance, supplier quality, supply chain efficiency, security and sustainability whilst establishing solid, sustainable and reliable partnerships according to the supplier segmentation. - Establish relationships with the sites' key stakeholders to ensure procurement alignment with their objectives. Share and communicate the procurement strategies of the own portfolio of materials/services, gain feedback and obtain their support and resources to achieve both objectives. Interface with the sites' procurement teams and provide the necessary guidance for the local implementation of the category’s strategies. - Ensured uniform approach to procurement spend in all sites for the respective categories. Enhanced co-operation between category management and local procurement teams leading to optimized performance (financial, compliance and technical). Full alignment in the organization and working towards common goals. - Negotiate purchasing terms and conditions to assure optimized. financial performance of purchased indirect materials and services and ensured compliance with the company's purchasing policy and working capital objectives. - Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner. - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the procurement tasks under her / his responsibility. - Gather relevant data to inform the decision makers regarding complex issues. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

- You will be the Hovione lead in charge of developing preclinical biology activities including DMPK (Drug metabolism and pharmacokinetics) and pharmacology scientific strategies for early projects and technologies in the field of drug delivery (oral, inhalation and injectables) supporting a wide range of therapeutic areas. - To that aim, you will manage, conduct and supervise preclinical biology activities to add value, support, and accelerate the development of Hovione’s innovative platforms. - Work in close collaboration with the project team and develop the scientific strategy for assigned projects - Apply strategic-thinking and forward planning to projects and implement the necessary actions to promote faultless execution - Propose new technologies and methodologies and the necessary investments and resources taking in account both project objectives and the group scientific and technical objectives and support their implementation - Manage the activities of assigned projects, by contributing to the design and execution of associated studies - Manage the outsourced activities, from provider selection until completion of project - Contribute and participate to scientific communication and events - Prepare documentation to support regulatory, IP, marketing or other cross-functional activities - As part of Hovione’s innovation model, contribute to licensing, external communication or external fund-raising activities  

Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.   Manage the full range of projects in the allocated area and solve complex problems with full autonomy. Project assignment will always be based on business need, however, preferentially, projects assigned will have a higher degree of complexity and more significant business impact including - a high cumulative sales / project cost value - a high project control level - a high customer segmentation level - Effectively supports project TMs and coaches less experienced PMs to enhance company effectiveness and promote achievement of high standards within the organization. - Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned. - Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or Company best practices. - Lead the project team to take decisions and influence key stakeholders with integrity. - Actively influence the project team composition and selection. - Clarify project team roles and responsibilities and enable others to optimize their use of technical, management and leadership skills. - Communicate proactively and effectively internally and externally, building rapport with key stakeholders. - Build and sustain motivation of the project TMs and positive dynamics within the project team. - Give timely and specific feedback to the project TMs regularly, both positive and constructive. - Propose innovative solutions, including processes and tools adjusted to the organization and market needs. - Demonstrate track record in project management. - Solve complex problems with full autonomy. - Make quality and timely decisions based on multiple sources of data and regarding a wide array of subjects. - Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals. - Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization. - Comply with all applicable GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs. - To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system. - Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities. - To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures. - To maintain good hygiene and housekeeping within the laboratory. - To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area. - Comply with the high standards in the QC Laboratories. - To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures. - To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories. - Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms. - Assist with audits as required, following the instruction of QC Management. - Undertake any additional tasks to support the laboratory activities as and when required. - Seek out additional information when one feels that the available information is not enough. - Follow all annual performance review requirements, including completion of the self-assessment. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Rigorously, accurately, efficiently and professionally manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations, escalating as appropriate - Propose new methodologies taking into consideration project demands and requirements - Execute project specific analytical tasks and act as a stakeholder liaison - Provide an example of professionalism and support the induction and training of new colleagues within the area - Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning - Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period - Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team as appropriate - Reviews work generated by the team as required ensuring all procedures are followed - Creation, investigation and evaluation of CAPAS, incidents and deviations - Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments - Accurately use and maintain all laboratory information systems - To maintain good hygiene and housekeeping within the laboratory - To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures - Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements - Assist with audits / investigations as required, following the instruction of QC Management - Support the generation / reporting of KPIs for the team, if required - Develop and accumulate strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area - Provide relevant training to other areas in accordance with established training plans - Participate, as required, in the induction and training of new colleagues - Drive high standards in the QC Laboratories - Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others - Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data - Work collaboratively in cross-functional teams and understand each departments function and role in delivery of tests and products - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the quality control tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.