Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
- Propose and implement complex and thorough HSE policies, procedures and guidelines in the areas of expertise as requested.
- Create incident reports and perform inspections to ensure conformity in the HSE areas of expertise.
- Lead internal audits in the HSE areas of expertise.
- Lead audits conducted by external parties.
- Propose and implement complex HSE systems and standards to facilitate the capturing and analysis of HSE statistics.
- Conduct complex risk analysis in the HSE area of expertise, proposing mitigation plans in the assigned projects.
- Lead the investigation of incidents/accidents as required.
- Lead regular inspections to the sites under responsibility in the HSE areas of expertise, ensuring conformity with all procedures and guidelines.
- Coordinate key HSE projects with operating and other technical units, guaranteeing the execution of the project.
- Contribute to the HSE training strategy and propose training goals and contents.
- Coach senior members of the company in HSE practices and principles.
- Delivery internal training sessions in the HSE areas of expertise to key people in the organization.
- Keep abreast of new legislation and regulations in HSE in the regions and area of expertise under responsibility.
- Demonstrate track record in HSE.
- 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.
- 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).
- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures and training.
- Design, project coordinarion and execution/qualification of strategic projects across all sites as part of the Global Engineering team;
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Performs automation and qualification activities on facilities, equipment and utility systems, according to regulatory demands (cGMP, GAMP, FDA requirements, etc), industry applicable guidelines and internal procedures;
- Planning, executing and supervising new or business continuity projects (MS Project, Meeting project deadlines and operation targets, milestones);
- Prepare Project Budgets and Coordinate outside contractors working on facility projects;
- Proactively develop, maintain, drive and communicate project timelines to broader cross-functional team on a weekly basis.
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 projects in the allocated area and escalate complex issues to more senior colleagues or managers. It is recognized that the level of support required will increase when projects that are more complex are assigned. Project assignment will always be based on business need, however, preferentially, projects assigned will have a low to medium degree of complexity including:
- a low to medium cumulative sales / project cost value
- a low to medium to high project control level
- up to a medium customer segmentation level
- 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 or to decide to escalate the decision based on data
- Contribute to the project team composition and selection
- Clarify project team roles and responsibilities
- Communicate proactively and effectively internally and externally
- 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
- Keep up to date on the best PM practices, standards and methodology in use within the industry
- 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 project management tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- 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
Delivers win-win cost-effective solutions on time and in full through a Team of Project managers leading 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. Enable and coach the Project Managers to 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.
Main responsibilities:
- Lead the development of the Project Management area vision, strategy and measures, ensuring these are aligned to the overall business, in collaboration with the Senior Director PMO.
- Develop and sustain standardized PM processes, implemented in a consistent and repeatable manner.
- Oversee the integration of program and project processes
- Develop organizational governance frameworks, hierarchies, and relationships
- Monitor portfolio, program, and project performance (actual versus planned) and key performance indicators.
- Implement a PM continuous improvement system, to optimize the existing processes and adapt to new challenges and realities, in the line with the overall Corporate PMO strategy
- Facilitate organization-wide stakeholder engagement and agreement, actively contributing to customer satisfaction
- Control area deliverables and ensures they are completed on time and in full and within budget, thereby exceeding customer expectations
- Assign program and project managers to programs and projects
- 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 area 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.
- Active member of the site leadership team influencing the strategic direction of the site and bringing the customers’ perspective to the attention of the SLT
- 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 TMs
- Responsible for overall sales, promoting and supporting the organisation’s services portfolio.
- Activities include developing and implementing sales strategies; managing and growing existing customer relationships; and monitoring customer and competitor activity and industry trends.
- Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers at a biotech and large pharma accounts.
- Identify, develop and close new sales opportunities with existing customers.
- Creates demand for Hovione’s CDMO services.
- Adapt departmental plans and priorities to address commercial challenges.
- Proactively communicate and support departmental managers as needed.
- Achieve sales targets and ensure project delivery for assigned portfolio of customer accounts.
- Build internal network within Hovione and customer accounts.
- Manage negotiations of CDAs, Master Service Agreements and Commercial Supply Agreements for allocated accounts in close collaboration with the Regional and/or Senior Directors in Sales
- Coordinate with the global regulatory, production, quality, supply chain and R&D groups to provide a superior level of customer service.
- Analyze data, including demand forecasting, within Hovione´s Customer Relationship Management system for Europe to ensure accurate forecasting and reporting.
- Identify complex market trends and demands and proposing ideas for new technology and services.
- Monitor customer account and market activity and provide concise and insightful analysis on customer dynamics, market developments and competitor activity.
- Optimize the relationship with established clients through both strategic and tactical means including Key Account Plans, Account Growth Plans, Periodic Business Reviews, client visits and Satisfaction Survey Action Plans
- Attend and represent Hovione at key Trade Shows
- 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.
- Resolve a wide range of technical aspects within multiple projects in order to reach the established targets
- Execute the projects according to the agreed work plan, selecting methods and techniques for obtaining the best solutions
- Give Technical Support to projects of the group not directly under own responsibility
- Present recommendations and builds on other’s ideas
- Generate technical documentation
- Contribute to the improvement of processes and procedures
- Communicate with clients on and other parties on project related topics
- Recommend methods and procedures on new or special assignments
- Develop new procedures and methodologies based upon experience and innovative approach
- Generate Intellectual Property and promote scientific activities & innovation
- Develop own and others’ competences
- Represent Hovione in external events, conferences, etc.
- Train staff in subjects related to own area specifics/expertise
- Participate in inspections and internal and external audits
- Network with peers internal and external outside own area of expertise
- Participate and lead peer reviews in own cross-functional teams and asset groups
- 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 Scientist’s 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
- Responsibility over inhaler device portfolio development: from conceptual design to manufacturing
- Create and evaluate device designs during the complete product life cycle, from conceptual level and IP generation, to detailed design and through manufacturing
- Drive the device product development based on solid engineering principles, knowledge of materials, manufacturing processes, finishing and assembly to develop functional, performant, cost-effective and robust device designs and finding trade-offs in the complex design space of a drug-device combination product
- Lead device verification testing through the product life cycle, identifying methods to test the designs, analyse the results and implement design changes based on these
- Technical lead for new technology implementation in device filling & assembly
- Prepare high-quality technical reports and documentation for supporting the Design History File
Act as servant leaders developing, coaching and supporting team members aligned with Hovione Supply Chain vision, mission and strategy. Promote cross-functional collaboration, effective communication and critical thinking to be able to improve rigor, discipline and predictability. Implement best practices and leverage on opportunities of standardization and harmonization between areas and sites based on continuous improvement and learning culture.
- Corporate function responsibilities include definition of best practices and standards in partnership with sites and areas
- Aligned with best practices and Corporate standards
-Guarantee the execution of the supply chain activities under responsibility (transportation, warehouse management, import/export, distribution and/or planning), with a long-term perspective and finding creative solutions
-Propose tactics to solve supply chain challenges, acting as a partner of production, maintenance, R&D and engineering
- Establish relationships with suppliers and customers to improve supply chain operations in terms of effectiveness, guaranteeing client satisfaction and timely delivery
-Oversee supply chain projects, giving direction and coordinating activities, in order to improve processes and systems
-Propose and guarantee the implementation of inventory targets and purchases of goods
-Create and implement supply chain metrics and KPIs ensuring its monitoring and control
-Define and guarantee the implementation of revisions on the supply chain methodologies and processes used, guaranteeing an increased efficiency (transportation, warehouse management, import/export, distribution and/or planning)
- Provide guidance in supply chain topics, keeping a good knowledge of processes, tools, legislation and methodologies (planning, scheduling, master data, warehouse management, import/export, transportation, distribution, etc.)
- 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´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures
- 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.
- 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
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).
- Lead the implementation of the corporate sustainability project, aligned with the company's strategic objectives;
- Identify opportunities to improve energy efficiency, reduce natural resource consumption and minimize environmental impacts;
- Coordinate and collaborate with cross-functional teams to implement sustainable initiatives in all areas of SC site;
- Conduct feasibility analyses and evaluate the implementation of clean technologies and innovative practices related to sustainability;
- Monitor and measure the company's environmental performance, setting targets and key performance indicators;
- Ensure compliance with applicable environmental regulations and sustainability standards;
- Communicate and promote sustainability efforts internally, engaging employees and encouraging active participation;
- Stay current on trends, best practices and technological advances in sustainability and environment;
- Identify Circular Economy Opportunities.
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
- Lead and manage the development, scale-up, registration/validation of drug development programs
- Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Provide technical assessment of new projects as well as technical support to other areas
- Generate Intellectual Property, write and submit patents and promote scientific activities & innovation
- Represent Hovione with clients during technical and business assessments
- Act as a resource and mentor to team members in own areas of technical expertise
- 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)
- 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.
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
- 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
Delivers excellence in end-to-end process improvement practices, methodologies and behaviors to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviors 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 behaviors 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.
- Develop and apply knowledge of process optimization and participate in area processes, procedures optimization projects with the guidance of more senior colleagues
- Take part in Continuous Improvement Initiatives, problem solving and risk assessment groups
- Deliver training on concepts as per training plans in place
- Ensure that all assigned tasks are delivered 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.
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)
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Perform and provide support to the development of analytical methods and the implementation of innovative and new analytical methodologies
- Coordinate priorities with Area responsible and Project manager to ensure that the timelines of the analytical work (such as method development, validation protocols, validation execution, and validation reports) of the project are met
- Prepare and revise analytical reports and protocols
- Actively participate in investigations and propose corrective and preventive actions (CAPA)
- Discuss actively with customers technical and scientific issues of projects under own scope
- Support client visits
- Discuss and review analytical data generated by the team
- Provide training internally and to other areas as required
- 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 Analytical 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.
- As Subject matter expert, you will be responsible for the technical strategic programme in the field of Inhalation
- Responsible for portfolio of projects within the programme, from ideation to launch including prioritisation, governance, resourcing and overall budget management
- Promotes the scientific excellence and innovation in the field of Inhalation and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Lead the development and implementation of Hovione’s R&D strategy for Inhalation
- Supervise projects within the field of Inhalation, providing technical expertise and support to the project leads ensuring the right networks are developed internally and externally
- Review complex projects within the area to promote innovative approaches leading to the generation of IP (patents or trade secrets)
- Liaise with key customers, supporting the Sales Team, to guarantee an informed discussion about Hovione technical competencies and capabilities
- Speak at Scientific Events and represent the company in international scientific forums
- Ensure the strategic programme supports business strategy and meets market needs
- Carry out 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
- Provide inspirational leadership to the team and strive for operational excellence, with higher quality, efficiency and at higher processing speed.
- Drive best practice and process efficiencies through continuous improvement increase overall efficiency;
- Benchmark shared services organization against other companies to identify and implement process improvements
- Identify and implement process and system improvements to
- Develop and provide KPIs and metrics to senior management
- Monitor the process of invoice posting for local and foreign vendors and liaising with third parties in case of irregularities
- Monitors vendor current account reconciliation with monthly statements and liaises with external auditors in this matter
- Provide technical guidance and assist less senior TM’s
- 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.
- Act as a subject matter expert to less experienced colleagues.
- Accomplishment of the local and international legislation applicable to the manufacture of active substances for use in the pharmaceutical industry (both human and veterinary use).
- Coordinate the approval and authorizes the release of the APIs for medicinal products in order to assure that the GMPs and, whenever applicable, the provisions of the marketing authorisation and/or drug master file are applied (for both human and veterinary use). Additional Responsibilities for Drug Product:
- Assure that every batch of medicinal products (MPs) or investigational medicinal products (IMPs) or active substances (APIs) both human and veterinary use, was manufactured and checked according to the quality requirements of the company, EU Good Manufacturing Practices (as per EU Directives 2001/83/EC, 2001/82/EC, 2003/94/EC), local legislation in force, International Guidelines (as applicable) and whenever applicable in accordance with the relevant marketing authorization/product specification file.
- Accomplishment of the local and international legislation applicable to the manufacture of Investigational Medicinal Products and Medicinal Products (both human and veterinary use).
- Coordinates the approval and authorizes the release/certification (as applicable) of the IMPs, MPs and intermediates for medicinal products in order to assure that the GMPs and, whenever applicable, the provisions of the marketing authorisation/product specification file are applied (for both human and veterinary use).
- Ensures compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) guidelines and regulations.
- Ensure that product quality related issues (e.g., recall, quality defects) are notified to the Customers or Health Products Regulatory Authority (as applicable) when product quality issue is of sufficient magnitude to affect the quality/ safety or efficacy of the product.
- Promote a Quality Culture and Continuous improvement of standards, through the constant oversight of all applicable Quality guidelines and regulations.
- Manages and coordinate the QP objectives and assure that they are in line with the company strategic plan.
- Communicates the quality and regulatory requirements to the different areas of the company.
- Acts as point of contact and communication of quality issues with the Health Authorities and clients.
- Represents Hovione in meetings with Regulatory Authorities and clients.
- Provides technical support to internal and external customers on product quality related questions.
- Assures that change control procedures consider regulatory marketing authorization implications, especially for critical changes requiring pre-approval, and to inform clients.
- Act as decision maker in topics related to legal responsibility of the Qualified Person.
- Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization.
- The following tasks may be delegated, but the QP should have an oversight on them: -Supplier Quality Management - Transparency of the entire supply chain
-Involvement in audits and their reports to enable signature of the QP-Declaration Template
