Quality Projects Associate
il y a 3 jours
This 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 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 filings Validation Act 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 - DHF Registration The 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 practice Profile: 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 products Quality mindset Pragmatic Excellent analytical and problem solving skills Excellent oral and written communication skills and social skills Scientific knowledge and skills Languages: fluent in Dutch and English Excellent knowledge of cGMP, regulatory guidance and relevant medical device and combination product regulations
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Quality Projects Associate
il y a 3 jours
2870 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 4 jours
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 Project Associate
il y a 2 semaines
Puurs-Sint-Amands, Belgique WhatJobs Temps pleinJoin a leading team providing essential quality oversight and project support within the pharmaceutical industry . This role offers you the chance to contribute significantly to quality assurance processes and product launches in a state‑of‑the‑art aseptic manufacturing environment. As the ideal candidate, you are a driven Quality Project Associate...
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Quality Projects Associate
il y a 3 jours
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 3 jours
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 Engineer
il y a 4 jours
2870 Puurs, Belgique Arcadis Temps pleinAs a Quality Engineer, you will play a key role in supporting and improving quality standards across the Utilities and Supporting Systems department. You will act as the coordinator for complex quality issues, serving as the link between the department and the quality team. Your proactive approach will help maintain high standards by monitoring key...
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Project engineering lead
il y a 3 jours
2870 Puurs, Belgique Jefferson Wells Temps pleinAntwerp – Contracting Our partner is looking for a Project Validation Coordinator to join its team. This international company is well known for its pharmaceuticals. The Project Validation Coordinator (VALCO) supports the project lead in coordinating the project team to achieve defined project deliverables related to validation, as well as the overall...
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PROJECT INGENIEUR freelance
il y a 3 jours
2870 Puurs, Belgique Arcadis Temps pleinAs a Project Engineer Formulation you will be responsible of the coordination of validation and planning activities in capital projects, including scheduling and managing project plans. Interpretation and application of GMP regulations (US, EU, ?), international standards (ISO, ICH), and Quality Standards Coordinating verification/validation activities,...
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Project Engineering
il y a 3 jours
2870 Puurs, Belgique Jefferson Wells Temps pleinAntwerp – Contracting Our partner is looking for a Project Validation Coordinator to join its team. This international company is well known for its pharmaceuticals. The Project Validation Coordinator (VALCO) supports the project lead in coordinating the project team to achieve defined project deliverables related to validation, as well as the overall...
