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 Youll 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 Manager Supplier Assurance as needed.
- Thrive in an entrepreneurial setting, and take accountability for results.
- Embrace challenge and change, applying a growth mindset approach.
- Have a bias for action and fast decision making.
- Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of One Team by working collaboratively across all business functions with an open, honest, and respectful cooperation.
- Contribute to making ADVANZ PHARMA a desired place to work.

What Were Looking For

Were looking for ambitious, resilient, and commercially minded professionals who are passionate about improving patient outcomes and driving business growth.

For this role, you will also have the following:

Qualifications:

- Degree or equivalent qualification in Pharmacy, Chemistry, Microbiology, Pharmaceutical Sciences, Life Sciences or a related scientific discipline.

- Recognised auditing qualification or formal auditor training, with demonstrated competency in GxP audit conduct.

Knowledge,



Skills Experience:

- 8-10 years of pharmaceutical auditing experience, including GMP audits of sterile manufacturing CMOs and aseptic manufacturing operations.
- Experience auditing a broad range of GxP suppliers, including manufacturers, distributors, laboratories and service providers.
- Proven experience leading, conducting and reporting GMDP audits of suppliers, CMOs, API manufacturers and GxP service providers.
- Strong expertise in assessing supplier quality systems, audit findings, CAPAs and compliance risks using a risk-based approach.
- Demonstrated experience supporting supplier qualification, requalification, vendor management and inspection readiness activities.
- Excellent written and verbal communication skills, including the ability to produce high-quality audit reports and communicate effectively with senior supplier representatives and internal stakeholders.
- A positive and can-do approach, biased towards finding solutions and embracing change
- Inspired by our values of entrepreneurship, speed and integrity
- Learning agility and scalability, with a desire to continuously improve and develop as ADVANZ PHARMA grows
- Work collaboratively across all business functions with an open, honest, and respectful cooperation
- Ability to have fun and thrive in a growing, unique, and inclusive work environment

Disclaimer : This job posting has been aggregated from external source. Role detailscontentand availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Specialist , Auditor (Mumbai)
🏢 Advanz Pharma
📍 Mumbai