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

  • P...

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