QA Officer

1 day ago

Dadra amp Nagar Haveli, India Stellar Formulations Full time

Role & responsibilities

  1. Documentation Issuance & Control
  2. Issue Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and logbooks to production as per SOP.
  3. Maintain master documents for BMR, BPR, SOPs, and other controlled documents with proper version control.

  4. Implement and maintain document control systems as per GDP and cGMP requirements.

  5. Batch Record Review & Compliance

  6. Review executed BMR and BPR for completeness, accuracy, and compliance with approved specifications.

  7. Coordinate with production to resolve discrepancies, deviations, and documentation errors.

  8. SOP & Change Control

  9. Assist in preparation, review, and revision of SOPs related to QA and documentation practices.

  10. Support change control, deviation, and CAPA processes related to documentation.

  11. Audit & Regulatory Support

  12. Ensure readiness for internal and external audits by maintaining accurate documentation.

  13. Provide necessary documents and records during inspections (USFDA, WHO, MHRA, etc.).

  14. Training & Coordination

  15. Train production and QA staff on Good Documentation Practices (GDP) and documentation SOPs.

  16. Coordinate with other departments for timely closure of documentation requirements.

  17. Data Integrity & Archiving

  18. Ensure compliance with data integrity principles in all document handling activities.
  19. Maintain systematic archival of controlled documents for easy retrieval and regulatory compliance.

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