- Handle QA activities as per GMP and regulatory requirements.
- Review and approve BMR/BPR, SOPs, specifications, protocols and reports.
- Ensure compliance with cGMP, WHO-GMP and company quality systems.
- Manage deviations, CAPA, change controls and investigations.
- Conduct internal audits and support customer/regulatory audits.
- Monitor documentation and batch release activities.
- Coordinate with QC, Production, Engineering and Warehouse departments.
- Ensure proper implementation of SOPs and quality procedures.
Preferred candidate profile
- Robust knowledge of GMP, GDP and Quality Management Systems (QMS).
- Experience in documentation, deviations, CAPA and change control.
- Good understanding of pharmaceutical manufacturing processes.
- Good communication, analytical and documentation skills.
- Knowledge of regulatory requirements and audit compliance.