
QA/QC PHARMA (Job code: PAC)
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.