Job Description for a Quality Assurance (QA) Manager Department: Quality Assurance Location: Surendranagar Reporting To: Head – Plant QA Job Responsibilities: • Ensure adherence to Good 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