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Quality Officer

🏒
Prothya Biosolutions
πŸ“ Amsterdam, Netherlands
πŸ“
Location Amsterdam
πŸ“…
Posted June 03, 2026
πŸš—
Commute Local Area
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Job Description

Responsibilities:

1. Batch Record Review

  • Batch record review
  • 2. Release Preparation

  • Support the release preparation activities, in order to generate a complete batch dossier package
  • 3. Deviation Management

  • Review, assess, and close minor deviations. - Perform basic Root Cause Analysis (RCA). - Escalate major and critical deviations to senior QA or management.
  • 4. CAPA Execution & Follow-Up

  • Initiate and execute CAPAs. - Track and ensure timely completion of CAPA actions. - Verify CAPA effectiveness and document findings.
  • 5. Quality Investigations & Compliance

  • Support investigations for minor product complaints and minor process deviations and events. - Ensure proper documentation and compliance with GMP regulations.
  • 6. Change Control Support

  • Support minor Change Controls related to deviations and CAPAs. - Ensure proper documentation of Change Control impact.
  • 7. Audit & Inspection Support

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    πŸ“ Location Details

    πŸŒ†
    City
    Amsterdam
    πŸ—ΊοΈ
    Country
    Netherlands
    πŸš—
    Commute
    Local Area

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