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)
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.
- Propose and implement complex logistics projects that have an impact on the efficiency and cost-effectiveness of the area (related with warehouse management, transportation, circuits and/or imports/exports)
- Implement complex processes and methodologies in logistics according to established guidelines (such as new regulations, legislation, policies and practices)
- Ensure that logistics policies are followed by the logistics teams, conducting controls, verifications and monitoring
- Prepare complex documentations related with logistics (such as warehouse management, transportation, circuits and/or imports/exports), analyzing and reviewing KPIs
- Communicate with external authorities, customers, suppliers in all relevant regions and countries to support logistics processes and solve complex problems
- Conduct complex analysis and reports related to logistics
- Optimize resources and procedures for continuous improvement
- Follow customer and authorities audits and inspections and guarantee the implementation of needed changes as requested
- Conduct investigation of events and propose corrective actions/preventive actions in logistics assuring the implementation on time of these actions
- Collaborate in the training of warehouse teams, proposing contents and delivering training sessions when required
- Keep a sound knowledge of current legislation and regulation in terms of logistics in the allocated regions
- Master logistics processes and tools (import/exports and/or warehouse management)
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- 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).
- 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, and other GMP related documentation for all processes run in operations;
- Participate and ensure, with supervision, 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 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;
- Report abnormal situations at the installations, as soon as these are detected, so that corrective maintenance is triggered in due time;
- Takes lead on non-complex projects / campaigns (with guidance) and supports the lead process engineer in complex projects / campaigns;
- Provide training on manufacturing processes to operational team members ensuring they are appropriately trained to perform the process related tasks;
- Initiate and prepare, with supervision, tech-transfers and process improvement projects for established processes utilizing best available technology, practices and tools;
- Contributes to the increase of productivity by reviewing and proposing the introduction of new technologies, methods and practices that have the opportunity to optimize the manufacturing processes.
Responsibilities
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.
 
- Apply and develop knowledge of Quality’s Computerized Systems and participate in area processes, procedures and projects of computerized system developed in-house or off-the-shelf,  with the guidance of more senior colleagues 
- Support the evaluation of design documents against regulatory and Hovione compliance requirements as well as throughout its life cycle 
- Apply a risk-based approach throughout the life cycle of the Computerized Systems taking into account patient safety, data integrity and product quality 
- Understand and apply policies for Computerized Systems life cycle management 
- Perform validation activities of the Computerized System projects and support teams to ensure compliance with Regulatory and Industry Standards throughout systems’ life cycle 
- Participate as part of multi disciplinary work groups with Quality Assurance, Information Systems, User Areas and other Departments/Sites and contribute to the adequate and timely completion of all validation activities 
- Collaborate in the definition of the required Qualification and Validation strategies for different Computerized Systems: Manufacturing equipment, DCS, PLC and other stand-alone software 
- Issue/prepare/execute/review protocols and reports (i.e., DQ, IQ, OQ and PQ), relating to the Qualification of Computerized Systems and other validation/qualification documents 
- Test all computerized systems to demonstrate its compliance with internal and external guidelines (such as 21CFR Part 11, GAMP, EU, PIC/s and ICH) 
- Support in reviewing Computerized System change controls, deviations, incidents submitted by any Department/Site 
- Support internal and external/ customers’ audits and health authorities’ inspections 
- Run all assigned tasks on time, safely, efficiently, reliably and in a cost-effective manner 
- 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.
Implement, maintain and improve Process and Equipment Automation systems including user interfaces, data collection and OT-IT interfaces. Contributes and lead Industry 4.0 initiatives and foster the technological innovation facilitating the introduction and the evolution of Augmented Reality, Digital Twin, Assets Management, IoT and Data Analytics solutions. Supports OT systems and plant operations including maintenance, GMP/HSE compliance, Inspection& Audit support, user training and ensures solutions sustainability. Build data pipelines and applies ETL techniques to convey data from automation systems to informatics system and create specific applications for notifications and automatic reporting. Collect, analyze and report process data to support decision on day-to-day operations and for continuous improvement. Develop, implement and deploy optimization algorithms/models. Map business and operation processes, suggest changes to streamline procedures and automate repetitive tasks using RPA techniques. Develop robotics prototypes for specific applications and evaluate its scalability.
- Develop automation systems to control industrial processes, choosing and programming a controller and establishing communication between the sensors, the actuators and the controller
- Design, simulate, install, test and maintain electrical and mechanical automation of industrial processes
- Monitor automation processes on an ongoing basis, identifying and implementing improvements
- Implement code changes under change control
- Investigate and provide technical advice to support production, maintenance and other engineering disciplines related with operations
- Conduct and support automation data collection and reporting systems, network systems and automation system security
- Develop, customize and use data models and algorithms to improve operations, automation and business processes.
- Implement, maintain and improve Process and Equipment Automation systems including user interfaces, data collection and OT-IT interfaces
- Collect and analyze process data to support decision on day-to-day operations and for continuous improvement
- Build data pipelines and applies ETL techniques to convey data from automation systems to informatics system and create specific applications for notifications and automatic reporting
- 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 operational technologies and data tasks under her / his responsibility
- 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.
- 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;
- 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 Change Controls (PdAs) to assure timely closure of deviations and approval of PdAs, as appropriate;
- Prepares SOPs, department IOPs, quality related reports and change control documents (PdAs) as required and appropriate;
- Review process master documentation, revision of executed batch documentation and product specifications as required and appropriate;
- Review regulatory documentation and co-ordination of site documentation to support regulatory requirements;
- Authorize the usage of production equipment/utilities when qualification required.
Responsibility over the development, scale-up, registration / validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Evaluate the needs of both the material and human resources for the area’s projects to guarantee that the right scientific support is given in time to customers
- Supervise all projects within his/her Group, ensures that execution is flawless and that adequate resources are allocated to meet the project goals and all deliverables are met in time for invoicing
- Define a development and validation strategy for new projects and establish the scientific and research plan within his/her Group
- Support the implementation of new and state of the art methodologies and/or equipment
- Review and approve the technical reports and documentation prepared in the Area
- Ensure the information flow between the laboratory and the several internal and external customers
- Support development activities and investigations, providing guidance and technical consultancy to teams across the organization, particularly in the problem solving process once escalation occurrs
- Monitor the performance of the group, implementing the necessary measurements for continuous productivity increase
- Promote scientific excellence and innovation within the team and support in the implementation of new technologies/methodologies
- 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 Communication´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
Responsibility over the development, scale-up, registration/validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Lead the technical aspects of multiple complex projects
- Assess different options and recommends an approach to deliver on the agreed work plan
- Provide troubleshooting support to less experienced Team Members
- Generate technical documentation related to own projects and review others
- Provide technical assessment of new projects as well as technical support to other areas
- Actively propose improvements of processes and procedures
- Generate Intellectual Property and promote scientific activities & innovation
- Develop/propose new methodologies/technologies to increase R&D efficiency
- Contribute to Hovione branding by actively participating in Scientific Events, speaking at conferences, etc
- Act as lead in inspections and internal and external audits related to R&D projects
- Represent Hovione with clients during technical and business assessments
- Network with senior internal/external personnel outside own area of expertise
- Act as a resource and mentor to TMs in own areas of technical expertise
- Train others in subjects related to own area specifics/expertise
- Master scientific investigation processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- 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
Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers and influencers at an assigned group of customer accounts that may include major strategic customers within a geographic or industry focus. Identifies, develops and typically closes new sales opportunities. Creates demand for the organization’s products and services by raising their profile with customers. Achieves revenue targets by increasing revenue spend per account. Negotiates, with autonomy, highly complex and long term contracts. May conduct regular status and strategy meetings with the customer’s senior management to understand their needs and link them to the organization's product/ service strategies.
- Create a long-term strategy for accounts under responsibility, defining and monitoring the annual plan and adjusting priorities throughout the year, maintaining an even workflow using all resources effectively
- Approve the annual plan of activities and targets for the strategic account managers under responsibility guaranteeing their contribution ensures the accomplishment of Hovione’s sales targets
- Identify new critical business opportunities in the strategic accounts, assigning its follow-up to a designated strategic account manager
- Identify market trends and demands and define ideas for new products and services, as well as new strategies for the development of the strategic accounts.
- Set product pricing of long-term commercial supply contract negotiations for strategic accounts
- Negotiate CDAs, Master Service Agreements and Commercial Supply Agreements for strategic accounts
- Partner with other members of the company´s leadership team to identify how strategic account management can help the company achieve its business and financial goals, namely with R&D, Marketing and Manufacturing.
- Attend and represent Hovione at key Trade Shows
- Manage 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 approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives
- Prepare and propose for superior approval the annual Strategic Account Management budget (accounts 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
- 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
- Support the Branding and Design area;
- Design, oriented towards Graphic Design, with specific training in the area;
- Content Creaction for Social Media;
- Digital implementation;
- Aptitude for video editing;
- Creativity and visual culture;
• Monitor and analyze treasury data and produce budgets, forecast and financial statements that provide
management with high quality steering information on treasury
• Ensure the filing and archiving of treasury documents in line with financial guidelines and legal
requirements to be able to trace back information and comply with legal requirements
• Monitor and report on corporate treasury results, treasury risk exposure and compliance to provide management information, initiate corrective actions and always maintain compliant
• Perform account reconciliations of balance sheet accounts affecting the treasury system such as cash, cash equivalents, investments, debt and sales • Administer daily cash flow • Prepare and reconcile debt schedules, assist in providing credit risk analysis • Maintain business relationships with bank officers for daily treasury operations • Lead moderate complex projects within the treasury area • 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 treasury 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.
- Guarantee cGMP compliance within the area, by assuring that all necessary procedures are implemented on the site, according to the products requirements and as established in specific Quality and Technical Agreements
- Manage teams and Team Members, ensuring the best organization of work to deliver on the key area objectives
- Manage complex cGMP programs
- Ensure the best structure, tools and prioritization to allow timely and quality release of products
- Ensure that plans are in place to regularly inspect the operational areas to verify compliance with cGMPs
- Lead clients and regulatory audits or inspections as required
- Manage and evaluate regularly data regarding the Key performance indicators established for the area, ensuring actions are taken whenever there are deviations
- Partner with the various areas to identify areas for improvement of how they work together
- Support a continuous improvement mind-set within the area to simplify and streamline how things are done within the area
- Assure that flexibility and simplicity are achieved through an entrepreneurship mind set and a “opt-in/opt-out” of procedures to meet the “fit for use” approach
- Approve complex IOPs, change control documents (PdAs), process and equipment related documentation as required
- 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 Communication´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.
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.
- Establish annual plans for improvement in accordance with past performance and company strategic goals
- Define long term targets for Business Transformation Implementation
- Mentor and facilitate teams that are implementing projects and problem solving
- Coach functional area teams in their daily communication meetings, ensuring that defined methods are properly used in all areas
- Coach Lean Leaders and/or Six Sigma Green Belts
- Develop Operational Excellence Training Program and run training sessions across all levels of the company
- Develop a Continuous Improvement (CI) process in the plant that is visible to all e.g. through indicators, working methods and visual management
- Lead projects that result in major business process improvements for the company
- Track and report project results to management, internally and externally
- Work closely with Project Sponsor and Operational Excellence Director to continuously review process and to eliminate barriers in projects
- Ensure that process improvements stay in place over time and assure their sustainability
- Develop site culture initiatives to establish and maintain the operational excellence culture
- Support the execution of Operational Excellence Maturity Assessment and other benchmarking exercises
- Manage complex projects with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- 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 .
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.
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.
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.
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- Performs engineering work in operations, production, construction or maintenance environments.
- Responsibilities are within the Engineering Family as a generalist or in a combination of disciplines.
- Understands the roles and workflows of the Engineering and Maintenance functions. Devise and coordinate working relationships between the area and other areas, including other Sites
- Establish the organizational structures of the area, anticipating or adapting to changing environment
- Contribute to the construction and review of the company strategy by adding his/her experience and technical knowledge to enrich such strategy
- 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.
- Appraise team performance, coaching team members to elevate their performance through development plans and address poor performance through improvement plans together with HR business partner.
- Identify and develop talent to guarantee future performance and area growth Ensure that team members assigned to area are trained in the required technical and behavioral competencies
- Identify and promote systems and procedures that will benefit the global organization
- Develop and propose for approval the, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives
- Define strategies and standards, aiming for CAPEX and OPEX optimization and knowledge management, to enable productivity, quality, cost competitiveness and safety.
- Guarantee technical solutions for challenges during the life cycle of installations without compromising the design purpose and the process functionality, quality and safety
- Select reliable and competent partner companies capable to support the life cycle of our facilities and equipment and our growth plans.
- Ensure that continuous improvement and lean thinking is used in all departmental activities Liaise with authorities to guarantee timely approvals of submissions, ensuring that facilities are design and operate within Regulatory, Nationals laws and Health authority requirements.
- Prepare and propose the annual area’s budget, 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
- 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, 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.
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.
- Manage and coordinate a Team of Quality Assurance Specialists, dedicated to Spray Drying Projects and Products;
- Provide technical support and expertise to solve operational issues with the Team and Clients (both internal and external);
- Manage the cGMP programs (e.g. validation, qualification, stability, environmental control), within the scope of the Team.
- Assure that products are released according to its quality and timing requirements;
- Streamline a continuous improvement culture, mitigating any tendency for complexity;
- Conduct regular inspections of the operational areas to verify compliance with cGMPs (e.g Internal Audits);
- Represent the QA function in clients and regulatory audits or inspections;
- Manage and evaluate regularly data regarding the Key performance indicators established for the area;
- Approve, on quality’s behalf, IOPs, change control documents and process related documentation;
- Evaluate/approve equipment cleaning, qualification protocols and reports;
- Coordinate the Team in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all team members are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity.
Seasoned professional to be the Hovione Quality Lead for medical devices applied to respiratory drug delivery. This function will play a key role in driving the changes needed to enhance our Quality System for the field of medical devices and combination products. Expected to have a high level of engagement with stakeholders from quality, R&D, business development, regulatory affairs, and sites, as well as with external partners, to drive alignment on quality & regulatory requirements and best practices on medical devices and combination products.
Implements and manages the required guidelines and applicable quality requirements for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized, and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises, and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to development, commercialization, and optimization across the full lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits, and other regulatory due diligence. Represents Hovione in professional associations, industry/trade groups.
- Promote the importance of high-quality work levels and the importance of a continuous improvement culture in all core company activities.
- Lead company-wide initiatives, ensuring plan definition and timely execution.
- Manage Corporate Quality key activities related with Medical Devices and Combination Products, such as Procedures, KPI’s, Training, Systems Management (e.g., Documentation management system, CAPA, Change Control, etc.).
- Align, review, and harmonize the applicable quality Systems and Tools within all Sites, according to the demands of the applicable Guidelines and providing proper deployment and training for the Company Sites as appropriate.
- Provide input into the assignment of Team resources for the necessary key area activities.
- Manage Audits/inspections (Internal and External – Suppliers, potential new Customers, Health Authorities) as applicable.
- Demonstrate track record in Quality/Regulatory Systems.
- 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 to prevent deviations to the goals.
- Coach other team members to enhance company effectiveness and promote achievement of high standards within the organization.
- 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 Quality, Regulatory and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, filings, systems, and procedures.
- May qualify as corporate GMP auditor.
