Senior GMP Quality Specialist

Our client is a leading company in the pharmaceutical manufacturing sector, committed to delivering high-quality health products. They operate in a dynamic environment that emphasizes safety, quality, and continuous improvement. The organization values teamwork, professionalism, and adaptability among its diverse workforce.

As a GMP Specialist, you ensure full GMP compliance within BU5 by overseeing documentation, change controls, deviations, and quality risk assessments in an LVV manufacturing environment. You support Operations and New Product Introduction (NPI) by translating technical processes into compliant, shop-floor-ready solutions aligned with Annex 1 standards. The role includes leading root cause investigations, managing non-conformances, and ensuring timely closure of deviations. You coordinate internal batch release activities and act as SME or primary contact during internal and external audits.

• Maintain and continuously improve GMP documentation to ensure ongoing compliance with cGMP and Annex 1 requirements.
• Author, review, and manage change controls related to GMP production processes and systems.
• Lead deviation investigations, perform root cause analysis, and ensure timely resolution of non-conformances.
• Facilitate and support Quality Risk Assessments (QRA) to identify and mitigate compliance risks.
• Coordinate internal batch release activities and support internal/external audits as SME or primary contact.

• Bachelor’s or Master’s degree in Science, Biotechnology, Engineering, Pharmacy, or a related field.
• 2–8 years of experience in a biotechnology or biopharmaceutical GMP manufacturing environment.
• Strong knowledge of cGMP regulations; familiarity with Annex 1 requirements is preferred.
• Experience with quality systems such as deviations, change controls, QRA, and electronic systems (e.g., Comet, TruVault).
• Excellent communication and stakeholder management skills in a complex matrix organization; fluent in English (Dutch is a plus) and proficient in Microsoft Office tools.

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