- Ensure compliance with cGMP, GLP, SOPs and regulatory requirements.
- Review and approve BMR/BPR, SOPs, specifications and quality documents.
- Handle Deviations, OOS/OOT, CAPA, Change Control and investigations.
- Monitor QA activities across manufacturing and ensure GMP compliance.
- Conduct and support internal, customer and regulatory audits.
- Coordinate validation, qualification and documentation activities.
- Handle market complaints, product recalls and quality investigations.
- Ensure data integrity and Good Documentation Practices (GDP).
- Prepare and review PQR/APQR and quality-related reports.
- Coordinate with Production, QC,
Engineering and other departments for quality compliance.
- Support regulatory inspections and ensure timely closure of audit observations.
- Train personnel on GMP, SOPs and quality systems.
Required Skills
- Strong knowledge of Pharma QA QMS
- GMP and regulatory compliance
- Deviation, CAPA Change Control
- Audit and inspection handling
- BMR/BPR and documentation review
- Validation qualification exposure
- Positive analytical, communication and coordination skills
- Knowledge of ERP/eQMS will be an added advantage
Required Qualification
B.Pharm/M.Pharm
Key Skills
- Oos/oot
- Capa
- Cgmp
- Glp
- Sops
📌 QA Executive (Dadra and Nagar Haveli and Daman and Diu)
🏢 Quality HR Services
📍 Dadra and Nagar Haveli and Daman and Diu
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