Lead - Analytical Quality Assurance - Biosimilar

The Lead – Analytical Quality Assurance is responsible for providing strategic and operational leadership to ensure the quality and compliance of all laboratory testing activities. This role oversees the review and approval of analytical documentation, ensures audit readiness, and supports cross-functional collaboration to maintain high standards of product quality and regulatory compliance.

Key Responsibilities:

• Oversee testing and release activities for Raw Materials, Packaging Materials, In-process, and Finished Products in compliance with cGMP and regulatory requirements.
• Review and approve:
  • Stability protocols and reports
  • Standard Test Procedures (STPs) and product specifications
  • Analytical method validation and transfer protocols/reports
  • Internal Reference Standard qualification and re-...