Senior Specialist, Auditor Mumbai

Senior Specialist, Auditor Mumbai

03 Aug
|
AdvanzPharma
|
Mumbai

03 Aug

AdvanzPharma

Mumbai

Job Title: Senior Specialist Quality Auditor
Location: Andheri, Mumbai (Hybrid working)

About the Role
As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Senior Specialist, Auditor to join our Supplier Assurance team.
This role is responsible for leading the supplier assurance and compliance programme by conducting risk-based GMDP supplier audits across the global supply chain. The position provides expert oversight of outsourced GxP activities, ensuring suppliers consistently meet regulatory, quality and company standards.
What You'll Be Responsible For

Plan, lead and execute risk-based GMDP audits of subcontracted and outsourced supply chain activities, including Contract Manufacturing Organisations, API manufacturers, distributors, laboratories, service providers and other critical GxP suppliers.
Manage the supplier audit programme, ensuring audits are planned, completed and followed up in line with GMDP requirements.




Conduct supplier quality risk assessments to support qualification, audit outcomes and compliance decisions.
Prepare audit reports and oversee supplier CAPAs to ensure effective issue resolution and inspection readiness.
Support supplier qualification, requalification and ongoing assurance activities, maintaining accurate supplier quality records.
Monitor global GMDP regulations and update audit standards, procedures and supplier oversight processes accordingly.
Develop and maintain audit documentation, including SOPs, templates, checklists and guidance materials.
Support regulatory inspections, customer audits and authority interactions as a supplier assurance subject matter expert.
Collaborate with cross-functional teams to ensure outsourced activities remain compliant and aligned with business objectives.
Represent the organisation during global supplier audits, provide technical guidance to quality teams, and deputise for the Senior Quality Manage

📌 Senior Specialist, Auditor Mumbai
🏢 AdvanzPharma
📍 Mumbai

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