Key Responsibilities

• Conduct audits across product categories (APIs, FDFs, Packaging materials)
• Ensure regulatory compliance (USFDA, EU GMP, etc.)
• Lead & Manage Regulatory Audits at Manufacturing Sites.
• 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

Skills

1. Quality Management Systems (QMS)

2. Vendor Management

3. Audits

4. CAPA Management

5. Contract Manufacturing

6. Regulatory Compliance

Qualification

Mandatory - B. Pharm

Experience Required Minimum - 10 Yrs