Quality Assurance And Regulatory Affairs Manager

We are looking for an experienced QA & Regulatory Affairs (RA) Manager with 10+ years of relevant experience in a regulated healthcare/biotechnology environment.

Key Requirements

• Strong hands-on experience in GMP principles, implementation, and compliance.
• Experience in planning, managing, and successfully facing GMP audits/inspections.
• Strong knowledge of Quality Management Systems (QMS), SOPs, deviations, CAPA, change control, and related quality processes.
• Experience in regulatory submissions and preparation/review of regulatory documentation and dossiers.
• Ability to coordinate with cross-functional teams and regulatory authorities.
• Excellent documentation, communication, and analytical skills.

Qualification

• M.Pharm / B.Pharm / M.Sc. / relevant Life Sciences qualification.
• Minimum 10 years of relevant QA/RA experience is mandatory.

Location: Ahmedabad
Relocation: Candidates not currently based in Ahmedabad must be willing to relocate.

This is an urgent position. Candidates who can join at the earliest will be preferred.