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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.
- Fulfill all applicable current Good Manufacturing Practices (cGMP) and Health Safety and Environment (HSE) regulations and relevant legislation by adhering to Hovione´s policies and procedures (COPs, HBR, SOPs and others) and industry standards while conducting all activities;
- Plan and design manufacturing processes that ensure the production of intermediates and final products according to the project plan (reliably, right first time, on time and within budget) and in compliance with cGMP, HSE regulations and internal policies and procedures;
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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.
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.
- To achieve results through others via permanently assigned transversal management accountability. 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 high degree of complexity including:
- a high cumulative sales / project cost value
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Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.
- Ensure cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications during the early design phases;
- Contribute to the design review phase of Engineering projects to ensure cGMP and adequate technical solutions are incorporated;
- Execute the construction, assembly, commissioning, and qualification of Engineering projects;
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The Sourcing Specialist Trainee will learn to make informed procurement decisions during the RFP2Bid and Cost Assessment Processes. This includes actively participating in Screening Meetings to assess potential supply constraints, mitigate risks, and ensure strategic and timeline alignment from the onset of new opportunities. The Trainee will also leverage technical knowledge in chemistry and chemical processes to optimize supplier selection, ensure compliance with industry regulations, and drive alignment between technical requirements and procurement strategies.
The REGENERAR project, spanning four years and commencing on March 1, 2024, aims to develop a non-viral delivery formulation up to TRL4 for gene editing applications. This formulation is intended to promote regeneration in tissues with limited self-repair capabilities.
The consortium comprises six partners from three EU Member States:
- Two academic institutions: University of Coimbra (Portugal) and...
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...
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...
- Support maintenance teams to maximize the availability of critical equipment safely and at the lowest cost by developing systematic planning, control, and reporting of maintenance tasks and necessary spare parts.
- Collaborate with Reliability in failure mode analysis processes in maintenance activities and Top...
- Conceive, design and implement engineering solutions on the specific areas of engineering projects, towards a successful project conclusion, in order to achieve the company established objectives;
- Prepare, revise and approve technical documentation of engineering projects, for conceptual, basic and detailed design phases;
- Ensure that project documents are complete and optimal for a competitive tender process;
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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.
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and...
Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions...
Performs procurement and sourcing functions which may include but are not limited to short and long-term category strategy development, supplier development and innovation enablement, commodity/services/goods procurement, outsourcing and vendor selection as well as project material sourcing/ planning/scheduling. Creates efficient integrated processes among internal functions and outside suppliers providing an efficient and transparent internal customer experience, compliant with quality assurance and sustainability requirements. Focuses resources on continuous improvement of the movement of materials through various processes and establishes key performance metrics and...
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.
Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established production schedules while managing internal resources (people & equipment) and fulfilling customer requirements.
- Prepare all manufacturing plans for the production lines under his (her) responsibility, managing...
- Process invoices of national and international vendors (services, products and assets)
- Conduct vendor current account reconciliation with monthly statements
- Verify calculations, checks or information
- Compile summaries of information related to documents processed
- Process travel expenses
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