Role & responsibilities

- Manage all Quality Assurance activities for sterile manufacturing (Injectables/Ophthalmic).
- Ensure compliance with cGMP, WHO and other international regulatory requirements.
- Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), SOPs, protocols, reports, and validation documents.
- Lead investigations for deviations, OOS, OOT, market complaints, and CAPA implementation.
- Oversee qualification and validation activities (Equipment, HVAC, Water System, Clean Room, Process Validation, Media Fill, Cleaning Validation).
- Ensure environmental monitoring, aseptic process compliance, and contamination control strategies are effectively implemented.
- Coordinate internal audits, vendor audits, self-inspections, and regulatory/customer audits.
- Review and approve change controls, risk assessments, and quality management system (QMS) documents.
- Monitor product quality trends, stability studies, and annual product quality reviews (APQR/PQR).
- Train and mentor the QA team on GMP, data integrity, and quality systems.




- Collaborate with Production, QC, Engineering, and Regulatory Affairs to ensure smooth manufacturing operations.
- Ensure data integrity (ALCOA+) and maintain audit-ready documentation at all times.

Preferred candidate profile

- Education: B.Pharm / M.Pharm .
- Experience: 10-17 years in Quality Assurance with at least 8 years in sterile manufacturing .
- Robust knowledge of international regulatory guideline and audit
- Hands-on experience in handling regulatory inspections and customer audits. .
- Strong understanding of QMS, CAPA, Change Control, Deviation, Risk Assessment, Validation, and Data Integrity.
- Excellent leadership, communication, problem-solving, and team management skills.
- Team Handing experience.

Employee Benefits

- Employee Health Insurance
- Employee Accidental Insurance
- 2nd & 4th Saturday Off
- AC Transportation Facility
- Attractive HR Policies

📌 Quality Assurance Manager -Sterile (Ahmedabad)
🏢 Opes Healthcare
📍 Ahmedabad