Manager QA / Regulatory Compliance - Pharma Consultancy Co- Mumbai.

HRD House; Mumbai; Sur place; INR 1 000 000 - 1 700 000; Plein temps

Résumé du poste

HRD House in Mumbai seeks a Manager/QA Regulatory Affairs consultant to oversee GMP audits, regulatory compliance activities, and remediation support for pharma clients. The role covers API and FDF sites, vendor audits, and CAPA review.

The candidate should have 5–8 years in QA/RA with exposure to Indian regulatory requirements, audit reports, and clear communication with senior management. Travel to client sites across India is expected.

Qualifications

• 5–8 years of experience in QA/RA in pharma manufacturing or consulting.
• Strong knowledge of Indian Drugs and Cosmetics Act, Rules, Revised Schedule M, CDSCO and State FDA requirements.
• Experience with GMP audits for API and FDF; capable of addressing regulatory inspections and remediation.

Responsabilités

• Plan and conduct GMP audits, gap assessments, and mock inspections at API and FDF sites.
• Audit vendors, CMOs/loan licenses, and testing laboratories.
• Review client CAPA plans and verify closure of observations.
• Advise clients on compliance with Drugs and Cosmetics Act, 1940 and Rules, 1945; assist with remediation after regulatory observations.
• Review and strengthen QMS elements: change control, deviations, OOS/OOT, CAPA, recalls; draft SOPs and validation documents.

Connaissances

GMP audits

Regulatory compliance

QA/RA

Report writing

Communication

Willingness to travel

Formation

B.Pharm / M.Pharm in QA or RA

Description du poste

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 good experience with regulatory inspection remediation
• 6. Candidate will be required to travel to client sites and manufacturing facilities across India.