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