Quality Assurance Specialist
Posted: Oct 19, 2025
Job Description
I am supporting a pharmaceutical and biotech organisation in their continuous quality excellence and manufacturing optimisation programs. To strengthen their QA operations, we are seeking a Freelance Quality Assurance Specialist to provide GMP support, documentation oversight, and compliance across multiple product lines.This is the opportunity to work on quality projects within a fast-growing organisation. Joining a collaborative QA team with a strong focus on continuous improvement, along with an attractive daily rate and contract renewal potential.Key Responsibilities:Support batch record review and product release in compliance with EU GMP standardsManage and investigate deviations, CAPAs, and change controls, including robust root cause analysisReview and maintain Quality Management System (QMS) documentationSupport international audits and inspections, including an accurate follow-upCollaborate with manufacturing, quality control, and validation teams to ensure compliance during tech transfer and validation activitiesContribute to continuous improvement initiatives, driving data-driven quality enhancementsEnsure documentation accuracy and traceability throughout the product lifecycleRequirements:3+ years’ experience in QA within a GMP-regulated environment (pharma or biotech)Vast knowledge of EU GMP, Annex 16, and ICH Q-series guidelinesHands-on experience with deviation/CAPA management, change control, and audit preparationProficiency with eQMS systems or SAPExcellent communication skills in English & GermanAvailable for freelance / interim assignments (3–5 days per week)Interested? - Apply directly or DM me for a chat about this opportunity!
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