• Review general LVV GMP documentation and delegate updates to maintain compliance.
• Write and facilitate change controls documenting introductions or modifications in GMP production processes.
• Lead deviations and root cause investigations, ensuring timely follow-up and closure of non-conformance records.
• Participate in and/or facilitate quality risk assessments (QRA).
• Coordinate, support, and prepare activities for internal and external audits, acting as Primary Contact, SME, scribe, or back-office lead.
• Coordinate internal batch release activities and ensure alignment with compliance requirements.
  
  What you’ll need to succeed
• Bachelor’s/Master’s degree in Science, Engineering, or a related field.
• 2–8 years of experience in biotechnology or biopharmaceutical GMP manufacturing environments.
• Strong working knowledge of current Good Manufacturing Practice (cGMP); familiarity with Annex 1 is preferred.
• Experience with quality systems (e.g., Comet, TruVault).
• Proficiency with Microsoft tools including Excel, Visio, SharePoint, Word, and PowerPoint.
• Excellent communication skills in English; Dutch is beneficial
• Strong influencing skills and proven stakeholder management abilities within complex matrix organisations.

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