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Freelance qa specialist – process & cleaning validation (gmp)

Anvers
CDI
Indépendant
Amoria Bond
Publiée le 7 avril
Description de l'offre

FREELANCE QA Specialist – Process & Cleaning Validation (GMP)Antwerp, Flemish region, Belgium| FREELANCE - CONTRACT |Pharmaceutical Environment | DUTCH language REQUIREMENT

Role OverviewWe are currently looking for a QA Specialist with strong expertise in process and cleaning validation to support activities within a GMP-regulated pharmaceutical environment .In this role, you will play a key part in ensuring that validation activities meet quality standards and regulatory requirements, while supporting both new product introductions and ongoing lifecycle validation .

Key ResponsibilitiesProvide QA support for process and cleaning validation activitiesReview and approve validation documentation (protocols, reports, risk assessments)Support New Product Introductions (NPI) and tech transfer activitiesContribute to Continued Process Verification (CPV) and lifecycle validationEnsure compliance with GMP and Annex 15 requirementsSupport audit and inspection readiness activitiesReview and oversee cleaning validation strategies and documentationPerform and assess MACO calculationsParticipate in cleaning quality reviews and monitoring activities

Key RequirementsMinimum 3–5 years of QA experience in a GMP environmentStrong knowledge of Annex 15Solid understanding of organic chemistryProven experience in process validation :New Product Introduction / Tech TransferCPV / lifecycle validationAudit supportProven experience in cleaning validation :Cleaning validation strategyValidation master plans, protocols, and reportsCleaning monitoring & quality reviewsMACO calculationsStrong document review and approval skills with high attention to detailDUTCH Language is a necessity

Candidate ProfileQuality-driven with a strong GMP mindsetDetail-oriented and structuredAble to work independently and cross-functionallyStrong communication skills

Why Join?Work in a highly regulated pharmaceutical environmentContribute to critical validation and quality activitiesBe part of a dynamic and collaborative teamOpportunity to work on NPI and lifecycle validation projects

Interested? Apply directly or reach out for more information.We welcome applications from all qualified candidates and do not discriminate based on age, gender, or any protected characteristic. Due to high application volume, responses may be limited.

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