Quality Projects Associate
il y a 1 mois
- Product Quality as the independent quality authority for product-related qualifications and validations of the assigned products.
- Compliant and right first time product launches within Quality Operations (QO)
- Regulatory CMC (= Chemistry, Manufacturing & Controls) compliance of the plant processes with the regulatory filingsValidationAct as quality authority in a consistent way, in compliance with cGMPs and current regulatory expectations, for the following qualification and validation documents:
- Process qualification/validation
- Method validation
- Filter validation
- Component qualification
- Raw material evaluation
- DHFRegistrationThe composition, production processes, specifications, analytical methods of the drug products are described in the registration dossiers of the different markets. The QPA is responsible to pursue regulatory CMC compliance of the site practice versus the registration dossiers. This is achieved by participating in the following processes:
- Data verification and QA review of initial marketing authorization filings and variations, responses to health authority queries, briefing documents for scientific advice meetings
- Performing compliance checks of the registration dossiers of the different markets versus the site practiceProfile:Master Degree
- Scientific discipline (eg. Pharmacy, Biomedical Sciences, Bio-engineer, ...)2 years of relevant experience in the pharmaceutical sector and/or medical device industry (or equivalent by acquiring a PhD) with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for (Bio-)Pharmaceutical productsQuality mindsetPragmaticExcellent analytical and problem solving skillsExcellent oral and written communication skills and social skillsScientific knowledge and skillsLanguages: fluent in Dutch and EnglishExcellent knowledge of cGMP, regulatory guidance and relevant medical device and combination product regulations
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Quality Projects Associate
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinThis project is part of the QO Launch Excellence department, which is the independent product-oriented quality organization that has certain responsibilities concerning validation, registration and implementation within the site. Each QPA is assigned one or more specific Launch Excellence product(s) for which he/she is responsible.- Product Quality as the...
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Quality Projects Associate
il y a 1 mois
Puurs, Belgique Arcadis Temps pleinThe Quality Project Associate focuses on quality oversight and project support where you will primarily deliver essential quality oversight and comprehensive project support for pharmaceutical processes and products within Belgian sites, specifically the aseptic manufacturing plant. You act as an independent quality authority for product-related...
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Quality Projects Associate
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinThe Quality Project Associate focuses on quality oversight and project support where you will primarily deliver essential quality oversight and comprehensive project support for pharmaceutical processes and products within Belgian sites, specifically the aseptic manufacturing plant. You act as an independent quality authority for product-related...
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Quality Projects Associate
il y a 3 semaines
2870 Puurs, Belgique Arcadis Temps pleinThis project is part of the QO Launch Excellence department, which is the independent product-oriented quality organization that has certain responsibilities concerning validation, registration and implementation within the site. Each QPA is assigned one or more specific Launch Excellence product(s) for which he/she is responsible. - Product Quality as the...
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Quality Support Project Engineer
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinDepartment As a center of excellence in technology, innovation and project management, the engineering department of our client in Puurs is working on the future of the site. The ICS team within Puurs is working actively on the automation and integration of systems and data flows. Thanks to the expertise and the use of new technologies, we can build robust...
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Quality Support Project Engineer
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinDepartmentAs a center of excellence in technology, innovation and project management, the engineering department of our client in Puurs is working on the future of the site. The ICS team within Puurs is working actively on the automation and integration of systems and data flows. Thanks to the expertise and the use of new technologies, we can build robust...
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Quality Support Project Engineer
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinDepartmentAs a center of excellence in technology, innovation and project management, the engineering department of our client in Puurs is working on the future of the site. The ICS team within Puurs is working actively on the automation and integration of systems and data flows. Thanks to the expertise and the use of new technologies, we can build robust...
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Project Validation Coordinator
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinThe Project Validation Coordinator is member of the Engineering Quality & Systems team and supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation.Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management...
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Project Validation Coordinator
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinThe Project Validation Coordinator is member of the Engineering Quality & Systems team and supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation.Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management...
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Project Validation Coordinator
il y a 3 semaines
Puurs, Belgique Arcadis Temps pleinThe Project Validation Coordinator is member of the Engineering Quality & Systems team and supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation. Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management...
