3 - 8 years

3 - 5 Lacs

Posted:1 day ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

1. Documentation & GMP Compliance

  • Review and approval of SOPs, specifications, STPs, and batch manufacturing records (BMR/BPR).
  • Ensure adherence to cGMP and regulatory requirements (WHO, USFDA, EU, MHRA).
  • Maintain and update master documents as per Quality Management System.

2. Batch Release Activities

  • Review of executed BMRs/BPRs and in-process records.
  • Coordinate with Production and QC for batch disposition.
  • Verify line clearance and ensure correct status labelling.

3. Quality Systems

  • Manage deviation, OOS, OOT, change control, CAPA, and incident investigations.
  • Conduct periodic internal audits and assist in external audits.
  • Ensure proper implementation of data integrity principles.

4. Shop Floor QA / In-Process Checks

  • Monitor production activities for compliance with SOPs and GMP.
  • Verify critical operations such as dispensing, sampling, and validations.
  • Perform inspections for hygiene, equipment cleaning, and environment monitoring (if applicable).

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