Website Ipca Laboratories
Join Ipca Laboratories – A Trusted Name in Global Pharmaceutical Excellence
About Ipca laboratories
Ipca Laboratories Ltd., a globally recognized pharmaceutical leader with a strong presence in APIs and formulations, invites experienced QA professionals to be part of its dynamic Quality team. With world-class manufacturing facilities approved by regulatory bodies like USFDA and MHRA, Ipca is committed to ensuring the highest quality standards in everything we do.
Position: Manager – Quality Assurance (QMS & Documentation Lead)
Location: Silvassa, U.T. of Dadra and Nagar Haveli and Daman and Diu, India
Department: Quality Assurance
Experience Required: 12 to 15 Years
Educational Qualification: B.Pharm / M.Pharm
Team Size Managed: 10–12 QA professionals
Role Overview
The QMS & Documentation Lead will play a pivotal role in strengthening Ipca’s Quality Assurance systems. This role is responsible for overseeing the Quality Management System (QMS), leading critical investigations, ensuring regulatory compliance, and managing all QA-related documentation. The candidate should have extensive experience in handling regulatory audits (especially USFDA/MHRA), driving quality culture, and mentoring QA teams.
Key Responsibilities
1. QMS Oversight
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Ensure end-to-end implementation and monitoring of QMS processes in compliance with cGMP, USFDA, and MHRA guidelines.
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Lead activities such as change controls, CAPA, training, internal audits, and management reviews.
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Continuously upgrade QMS practices in alignment with evolving regulations and industry trends.
2. Handling Investigations & Compliance
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Independently manage critical investigations including OOS, OOT, deviations, and customer complaints.
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Ensure thorough root cause analysis and timely implementation of effective CAPAs.
3. QA Documentation Management
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Oversee all QA documentation including SOPs, batch records, validation protocols, and specifications.
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Maintain documentation accuracy, compliance, and traceability for audit readiness.
4. Regulatory & Customer Audit Management
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Act as the site’s QA representative during USFDA/MHRA inspections.
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Prepare responses to audit findings and ensure timely implementation of commitments.
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Host and manage customer audits and regulatory inspections confidently and effectively.
5. Team Leadership & Development
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Lead, coach, and mentor a QA team of 10–12 members.
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Assign responsibilities, review team performance, and foster professional growth.
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Promote a quality-centric and collaborative work culture.
6. Cross-functional Collaboration
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Work closely with Manufacturing, QC, RA, and Supply Chain teams.
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Represent QA in cross-functional meetings to ensure alignment and compliance.
Why Join Ipca?
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Work in a globally compliant facility with exposure to international regulations.
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Contribute to high-impact quality processes in a reputed pharmaceutical company.
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Be part of a collaborative and high-performing QA team.
Application Details
📧 How to Apply:
Interested candidates may send their CVs to tejal.bhandari@ipca.com
📌 Subject Line: Application for Manager – QA (QMS & Documentation Lead)
📅 Last Date to Apply: 20th June 2025
To apply for this job email your details to tejal.bhandari@ipca.com