GMP Documentation Specialist, Leiden, Zuid-Holland

About the Company
An innovative biotechnology organization is expanding its manufacturing capabilities with a new facility focused on advanced viral vector production. This site will support the development of life?changing therapies and is preparing for commercial readiness. The teams operate in a highly regulated environment and are committed to safety, quality, and cutting?edge biotechnology.
 
Role Overview
As a GMP Documentation Specialist, you will play a critical role in ensuring compliance, documentation accuracy, and operational readiness within the new viral vector manufacturing unit. You will act as a subject?matter expert on GMP processes, support the wider Operations and Technical departments, and help translate new processes into robust, compliant operations for the production facility.
This position is essential for securing batch readiness, audit preparedness, and continuous improvement within a high?quality, GMP?regulated environment.
 
Key Responsibilities
-Review and maintain GMP documentation to ensure compliance and alignment with regulatory expectations.
-Lead and support change controls related to production processes and documentation updates.
-Manage deviations, conduct root cause investigations, and ensure timely closure of non?conformance records.
-Participate in Quality Risk Assessments (QRA) and support risk?based decision?making.
-Coordinate and support internal and external audits in roles such as SME, Primary Contact, Scribe, or Back?Office Lead.
-Support internal batch release processes and ensure timely preparation of required documentation.
 
Requirements
-Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Engineering, or a related field.
-2–8 years of experience in a biopharmaceutical or biotechnology GMP manufacturing environment.
-Strong knowledge of cGMP standards; experience with Annex 1 is highly preferred.
-Experience with quality systems such as Comet, TruVault, or similar (e.g., TrackWise, Veeva).
-Strong attention to detail and analytical skills.
-Excellent stakeholder management in a matrix organization.
-Experience with deviation investigations and change control management.
-Proficiency with Microsoft Office tools: Excel, Visio, SharePoint, Word, PowerPoint.
-Strong communication skills in English; Dutch is a plus.
 
Apply Now
Ready to contribute to a cutting?edge biotech environment and support the launch of a new manufacturing facility?
Submit your CV today — we’d love to connect with you.

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