Corporate Quality Assurance Manager

2 weeks ago

Mumbai, Maharashtra, India V. S. International Pvt. Full time ₹ 15,00,000 - ₹ 20,00,000 per year

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

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