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

Deputy Manager - Quality Assurance (Surendranagar)

Job Description

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