02 Aug
|
Advanz Pharma
|
Mumbai
02 Aug
Advanz Pharma
Mumbai
Senior Specialist – Quality Auditor
? Andheri, Mumbai (Hybrid)
Join ADVANZ PHARMA and help improve patients' lives by increasing access to medicines that matter.
We are seeking an experienced Senior Specialist – Quality Auditor to join our Supplier Assurance team. This is a key role responsible for leading the global supplier assurance programme through risk-based GMDP audits, ensuring compliance across our outsourced supply chain and maintaining the highest quality standards.
Key Responsibilities
Lead and execute risk-based GMDP audits across CMOs, API manufacturers, distributors, laboratories, service providers, and other critical suppliers.
Manage supplier audit activities, including planning, reporting, CAPA management, and follow-up.
Conduct supplier quality risk assessments to support qualification, compliance decisions, and ongoing oversight.
Support supplier qualification, requalification, vendor management, and inspection readiness activities.
Maintain audit procedures, SOPs, templates, and supplier assurance documentation.
Monitor evolving global GMDP requirements and drive continuous improvement of supplier oversight processes.
Partner with cross-functional stakeholders and act as a subject matter expert during inspections, regulatory interactions, and customer audits.
What We're Looking For
✅ Degree in Pharmacy, Chemistry, Microbiology, Pharmaceutical Sciences, Life Sciences, or related discipline
✅ Formal auditing qualification/training with proven GxP auditing expertise
✅ 8–10 years' pharmaceutical auditing experience, including:
GMP audits of sterile and aseptic manufacturing operations
Auditing CMOs, API manufacturers, distributors, laboratories, and GxP service providers
Supplier qualification, vendor management, CAPA review, and compliance risk assessment
✅ Solid communication, stakeholder management, and audit reporting skills
✅ A proactive, solutions-focused mindset aligned with our values of Entrepreneurship, Speed, Integrity, and One Team.
📌 Sr. Specialist Quality Auditor (Mumbai)
🏢 Advanz Pharma
📍 Mumbai