Manager - Corporate QA

Job Description

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