Contracting – Brabant Wallon In collaboration with the appropriate management, the QA Packaging and medical devices Officer is responsible for the implementation and maintenance of an effective quality management system at the company's site: Ensuring that operations related to the packaging of finished pharmaceutical products comply with national and/or international regulations and guidelines (GMP), as well as the company quality policies Ensuring that registered finished products are produced and supplied to markets in accordance with the company quality standards Proactively assisting operations in identifying, developing, and implementing quality improvements and operational excellence in response to business requirements, technical changes, and regulatory requirements Monitoring of quality deviations, temporary and permanent change control, CAPA Support for market complaint investigations with responsible pharmacists Writing and follow-up of annual quality reviews of packaging lines Support for OOS (Out of Specification) investigations on packaging accessories Review and approval of packaging and quality assurance procedures Review and approval of qualification documents for packaging equipment Review and approval of cleaning validation documents for premises and packaging equipment Review and approval of process validation documents Support for customer audits and inspections related to packaging Review of various quality documents such as metrological specifications, engineering plans, risk analysis, training matrix, coaching, etc. QA support for projects defined by the packaging department Support for QA projects defined by QA management. Scientific master's degree. Approximately 4 years of experience as an on-site QA in a pharmaceutical production environment. Knowledge of QA Packaging (blistering, bottling, syringe assembly in combination products) is an asset. Fluent in French and English. Jefferson Wells offers you a permanent contra... GMP, Medical Devices, Maintenance, Quality Improvement, Audit, Finished product, Coaching, Asset, Process Validation, QA management, Projects, Inspection, Investigations, Monitoring, Training, Policy, Writing, Engineering, VOS, Risk Analysis, Bottling, Quality Control, Quality Reviews, Assembly, Management, Operations, Packaging, Change Control, Quality assurance, CAPA, Science, Quality assurance, Implementation, 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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