Manager - Corporate QA

Role & responsibilities

• Conduct audits across product categories (APIs, FDFs, Packaging materials)
• Ensure regulatory compliance (USFDA, EU GMP, etc.)
• Lead & Manage Regulatory Audits at Manufacturing Sites, including EUGMP audits.
• Ensure implementation of uniform quality systems across manufacturing sites.
• Review & approval of quality technical agreements with QP and customers.
• Approval of Change control impacting quality systems facility changes and other critical changes.
• Evaluate and oversee CAPA implementation and effectiveness.
• Develop training programs for internal auditors
• Support regulatory inspections (USFDA, EU, etc.)
• Review Annual Product Quality Review (PQR).
• Coordinate CMO site activities related to GMP auditing and batch release.
• Oversee Global digitization goal and CSV related initiatives.
• Perform vendor audits and maintain approved vendor list

Preferred candidate profile

Mandatory Exp in handling audits such as Regulatory, TGA, EU & UK MHRA.

Qualification- B. Pharm

Experience Required Minimum 15-20 yrs.

Min. 5yrs exp. in manufacturing / IPQA. in OSD.

Interested candidate may share their resume on :-

gita.hr@vsinternational.co.in