Related skills
gmp sops capa cgmp trackwise📋 Description
- Review and approve qualification documents and quality records to maintain regulatory compliance.
- Collaborate with engineering teams on new/upgraded systems; advise on qualification activities and CGMP.
- Address deviations during qualification activities.
- Communicate status (quality, compliance & planning) to the QA qualification team.
🎯 Requirements
- University/Bachelor’s Degree or Equivalent.
- Experience in chemical/pharma equipment qualification.
- Knowledge of cGMP regulations and guidelines.
- Fluent in English and Dutch (spoken and written).
- Trackwise/Comet experience for change controls.
- TruVault and Kneat experience.
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