Deputy Manager - Quality Assurance (Surendranagar)

SAVA Group; Surendranagar; On-site; INR 1,500,000 - 1,900,000; Full time

Job summary

SAVA Group is seeking a Quality Assurance (QA) Manager to lead compliance with cGMP, GDP and regulatory requirements. The role covers document control, QMS maintenance, SOP implementation, and coordination of audits and CAPA across departments.

The incumbent will review master documents, oversee validation/changes, and supervise QA activities to ensure batch release readiness and regulatory readiness.

Qualifications

• Knowledge of cGMP, GDP and regulatory requirements.
• Experience in document control, master documents and QA systems.
• Audit handling and cross-functional coordination.

Responsibilities

• Ensure GDP and GMP adherence across the site.
• Oversee Document Control Cell: review, draft, finalization and master docs.
• Maintain and improve the Quality Management System (QMS).
• Verify and implement SOPs in QA and coordinate with other departments.
• Review Site Master File, VMP and Quality Manual documents.
• Coordinate validation activities: process, cleaning and equipment.
• Handle Change Controls, Deviations, OOS, OOT, CAPA and nonconformities with relevant teams.
• Review qualification and validation protocols and reports.
• Contribute to updating the company Quality Manual.
• Plan and conduct internal and vendor audits and quality training.
• Review QMS trends and APQR; conduct on-the-job training.
• Manage review/control of BMR/BPR and batch release for dispatch.
• Serve as QA Lead in absence of Head - Plant QA to ensure continuity.

Skills

cGMP knowledge

QMS knowledge

Regulatory knowledge

Education

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

Job description

12 Years

Full-Time

Job Description for a Quality Assurance (QA) Manager

Department: Quality Assurance

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