Job Description:

Position: AGM/GM - Quality

Location: Daman

Experience: 15 - 25 Years

Industries: Pharma

Responsibilities:
- Site Quality Leadership:
- To establish and maintain a robust Quality Management System (QMS) aligned with regulatory expectations.
- To represent the organization as the Quality Management Representative during internal, external,
- and regulatory inspections, ensuring successful outcomes and continuous compliance readiness.
- Quality Management System (QMS) Ownership:
- To ensure compliance of deviation management, change control, Market Complaint Recall, CAPA systems, OOS, risk assessments, and investigations with regulatory and quality standards.
- To ensure for cGMP/GLP/GDP/GEP followed by all personnel.
- To manage batch release processes, ensuring timely review and disposition in alignment with GMP requirements.
- To manage document control, master batch records, validation protocols, and ensure timely periodic reviews.
- To led continuous improvement initiatives to enhance the Quality Management System (QMS) and drive operational excellence.




- Audit Exposure:
- EU-GMP, US-FDA, WHO, PIC/s, ANVISA
- Batch Release and Product Quality Oversight
- To ensure timely review and approval of Batch Manufacturing Records, Quality Control (QC) reports, and Certificates of Analysis (COA).
- To execute QA release for commercial and validation batches, including product quality review and compliance verification.
- Training and Development
- To establish and led training programs on GMP, GDP, Data Integrity, and regulatory updates for QA and cross functional teams.
- To build quality culture across the site through continuous learning initiatives and behaviour-based quality systems.
- Cross-functional Collaboration
- To collaborate with Engineering, Quality Control (QC), Regulatory Affairs, Supply Chain, and Corporate Quality teams to ensure smooth execution of compliance activities and alignment with regulatory quality standards.
- Risk Manageme

📌 AGM/GM - Quality (Diu)
🏢 Quality HR India
📍 Diu