- Develop, implement, and maintain Quality Management Systems (QMS) in compliance with GMP, GLP, and applicable regulatory guidelines.
- Prepare, review, and approve SOPs, specifications, protocols, reports, and controlled quality documents.
- Manage CAPA, change control, deviations, risk assessments, complaints, and document control.
- Conduct internal audits, vendor audits, and support external regulatory inspections.
- Ensure GMP compliance across laboratory and manufacturing operations through regular monitoring and training.
- Prepare and coordinate regulatory submissions, product dossiers, technical files, and responses to regulatory queries.
- Liaise with regulatory authorities and support product registrations, approvals, and lifecycle management.
- Review batch records, quality documentation, validation protocols, and qualification reports.




- Drive continuous improvement initiatives and ensure compliance with applicable quality standards.
- Train cross-function
- Robust knowledge of GMP, GLP, GCP, ICH, CDSCO, and applicable international regulatory guidelines.
- Experience in regulatory submissions, dossier preparation, and regulatory compliance.
- Hands-on experience with QMS, CAPA, deviations, change control, risk management, and document control.
- Experience in conducting audits and handling regulatory inspections.
- Excellent documentation, analytical, communication, and leadership skills.

Preferred candidate profile

- M.Pharm, M.Sc., B.Pharm, Biotechnology, Life Sciences, or related discipline.
- 56 years of experience in Quality Assurance and Regulatory Affairs within the pharmaceutical, biotechnology, or life sciences industry.

📌 Quality Assurance And Regulatory Affairs Manager (Ahmedabad)
🏢 STEMCYTE INDIA THERAPEUTICS
📍 Ahmedabad