Posted 2 months ago
  • Ensure compliance with GMP (Good Manufacturing Practices).
  • Perform internal audits and inspections.
  • Review and approve batch manufacturing records (BMRs).
  • Handle deviations, CAPA (Corrective and Preventive Actions), and change controls.
  • Develop and implement quality management systems (QMS).
  • Ensure regulatory compliance with FDA, EMA, and other agencies.
  • Conduct supplier and vendor audits.
  • Train employees on quality standards and guidelines.
  • Prepare validation protocols (IQ, OQ, PQ).
  • Manage documentation such as SOPs, protocols, and records.
  • Handle electronic documentation systems (EDMS).
  • Ensure compliance with pharmacopoeia standards (USP, EP, BP).
  • Investigate out-of-specification (OOS) results.
  • Maintain and calibrate analytical instruments (HPLC, GC, etc.)
  • Coordinate with QA and production for quality-related matters.

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