Job highlights

- Ensure adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) across the site

- Manage the review and control of BMR / BPR and coordinate for batch release for dispatch

for a Quality Assurance (QA) Manager

Department : Quality Assurance

Location : Surendranagar

Reporting To : Head Plant QA

Job Responsibilities

- Ensure adherence to Valuable Documentation Practices (GDP) and Good Manufacturing Practices (GMP) across the site.

- Responsible for Document Control Cell including review, draft circulation, finalization, and preparation of master documents.

- Maintain and continuously improve the Quality Management System (QMS) .

- Verify and implement Standard Operating Procedures (SOPs) in QA and coordinate implementation in other departments.

- Review master documents such as Site Master File (SMF) , Validation Master Plan (VMP) , and Quality Manual (QM) .

- Coordinate and oversee validation activities , including process, cleaning, and equipment validations.

- Handle Change Controls , Deviations , Out of Specification (OOS) , Out of Trend (OOT) ,



Market Complaints , Corrective and Preventive Actions (CAPA) , and Nonconformities , in coordination with relevant departments.

- Review and approve qualification and validation protocols/reports .

- Actively participate in the development, maintenance, and updates of the company s Quality Manual .

- Plan, coordinate, and implement internal audits , vendor audits , and quality training programs .

- Review QMS trends and Annual Product Quality Review (APQR) .

- Conduct on-the-job training for personnel from Production, Stores, Engineering, and QC departments.

- Manage the review and control of BMR/BPR and coordinate for batch release for dispatch.

- Serve as the QA Lead in the absence of the Head Plant QA , ensuring continuity of all QA functions.

Qualifications

- B.Pharm / M.Pharm / M.Sc.

- Strong knowledge of cGMP, QMS, and regulatory requirements

- Audit handling and cross-functional coordination skills

📌 Deputy Manager - Quality Assurance (Surendranagar) (Chennai)
🏢 Sava Healthcare
📍 Chennai