Role & responsibilities

1. As a Manager or Quality consultant (QA / Regulatory Compliance) will be based at Mumbai & work for reputed Pharma consultancy firm handling all matters.
2. The candidate will be responsible for planning and conducting GMP audits, gap assessments, and mock inspections at API and FDF manufacturing sites
3. Candidate will be responsible for audit vendors, contract manufacturers (CMOs/loan licenses) and testing laboratories.
4. Candidate will be responsible for review client CAPA plans and verify effective closure of observations. Regulatory compliance domestic market.
5. Candidate will be responsible for advise clients on compliance with the Drugs and Cosmetics Act, 1940 and Rules, 1945, including Revised Schedule M. and assist with remediation after regulatory observations (e.g. FDA 483s, warning letters). Client advisory and training.
6. Candidate will be responsible for Review and strengthen QMS elements change control, deviations, OOS/OOT, CAPA, market complaints, recalls and APQR. Review and draft SOPs, validation and qualification documents, and site master files.

Preferred candidate profile

1.



Candidate should have 5-8 years of experience in QA / RA in pharmaceutical manufacturing or consulting and Qualification B. Pharm / M. Pharm in Quality Assurance or Regulatory Affairs. PhD candidates with relevant experience in QA/RA and experience in Pharmaceuticals (API and Finished Dosage Forms).
2. Candidate should have good knowledge of Hands-on experience conducting or facing GMP audits for both API and FDF. Strong working knowledge of Indian regulations: Drugs and Cosmetics Act and Rules, Revised Schedule M, CDSCO and State FDA requirements.
3. Candidate should have good knowledge of Clear report writing and confident communication with plant and senior management teams. Willingness to travel frequently.
4. Candidate should have good knowledge of Exposure to US FDA, EU GMP, WHO-GMP, PIC/S or other ROW market requirements.
5. Candidate should have valuable experience with regulatory inspection remediation
6. Candidate will be required to travel to client sites and manufacturing facilities across India.

📌 Manager QA / Regulatory Compliance - Pharma Consultancy Co- Mumbai.
🏢 HRD House
📍 Mumbai