Company: Ipca Laboratories Limited
Location: Piparia (Silvassa), U.T. of Dadra and Nagar Haveli and Daman and Diu, India
Department: Quality Assurance
Experience Required: 12 to 15 years
Qualification: B.Pharm / M.Pharm
Team Size: 10-12 direct reports
Job Summary
Ipca Laboratories Limited, a leading pharmaceutical company, is seeking an experienced QA Manager – QMS & Documentation Lead for its Formulation (OSD) Unit in Silvassa. The ideal candidate will oversee the Quality Management System (QMS), ensuring compliance with USFDA, MHRA, and cGMP guidelines. This leadership role involves managing investigations (OOS/OOT), deviations, customer complaints, and regulatory audits while mentoring a team of QA professionals.
Key Responsibilities
✔ QMS Management:
- Implement and maintain Quality Management Systems in line with USFDA & MHRA regulations.
- Ensure robust execution of change control, CAPA, training, and internal audits.
✔ Investigations & Compliance:
- Lead OOS, OOT, deviation, and complaint investigations with root cause analysis.
- Oversee CAPA implementation and effectiveness monitoring.
✔ QA Documentation:
- Manage SOPs, batch records, validation documents, and quality agreements.
- Ensure all documentation meets regulatory compliance.
✔ Regulatory & Audit Management:
- Represent QA during USFDA, MHRA inspections, and customer audits.
- Ensure site readiness for regulatory and customer audits.
✔ Team Leadership:
- Mentor and develop a team of 10-12 QA professionals.
- Foster a culture of quality, compliance, and continuous improvement.
✔ Cross-functional Collaboration:
- Work closely with Manufacturing, QC, Regulatory Affairs, and Supply Chain.
About Ipca Laboratories Limited
Ipca Laboratories is a globally recognized pharmaceutical company specializing in generic formulations, APIs, and finished dosages. With a strong presence in regulated markets (US, Europe, and more), Ipca is known for its high-quality, affordable medicines. The company operates multiple WHO-GMP & USFDA-approved plants and is committed to innovation, compliance, and patient safety.
Why Join Ipca?
✅ Work in a USFDA & MHRA-compliant facility
✅ Career growth in a leading pharmaceutical company
✅ Competitive salary & benefits
Eligibility Criteria
- Education: B.Pharm / M.Pharm (Pharmacy degree mandatory)
- Experience: 12-15 years in pharma QA (OSD formulation preferred)
- Skills Required:
- Strong knowledge of USFDA, MHRA, cGMP
- Expertise in QMS, deviations, OOS/OOT, CAPA
- Experience in regulatory inspections & audit management
- Leadership skills to manage 10-12 QA professionals
How to Apply
Interested and eligible candidates can apply by following these steps:
- Prepare an updated resume highlighting relevant experience.
- Email your application to the designated HR email (if provided in the official job posting).
- Mention “Application for QA Manager – QMS Lead” in the subject line.
- Submit before the deadline (see below).
Interested candidates can share their updated resume 📧 on our email address tejal.bhandari@ipca.com with subject line “Manager – QA”
Contact No. 📞 (0260 6624406/ 471), 09687607002
Note: Only shortlisted candidates will be contacted for further interviews.
