Contracting – Antwerp 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 for pursuing 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. Implementation Ensure correct and timely implementation of approved regulatory changes in the site: follow-up on approvals and commitments in the different markets. Master's degree in scientific discipline 2 years of relevant experience in the pharmaceutical sector and/or medical device industry with specific experience or interest in Quality Assurance or Compliance and in regulatory affairs (CMC) for 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 guidances and relevant medical device and combination product regulations. Jefferson Wells offers you a permanent contract a... Chemistry, Filing, Health System, Social Skills, Manufacturing, Validation, Projects, Quality assurance, Method validation, Pharmaceuticals, Regulation, Raw material, Pragmatism, VOS, Evaluation, Medication, Problem Management, Registration, cGMP, Analytical methods, Operations, Regulatory Affairs, Product Quality, Regulatory Change, Data Verification, Quality assurance, Marketing, Medical Devices, Product Launches, Regulatory Filing, Science, Compliance check, CMC, Composition, Implementation, Briefing, Pharmaceuticals Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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