PURPOSE OF THE ROLE :To ensure accurate and compliant analytical method validation for injectable products, supporting regulatory requirements and product quality. Without this role, validated methods for testing would not be available, impacting product release and compliance.To ensure accurate and compliant analytical method validation for injectable products, supporting regulatory requirements and product quality. Without this role, validated methods for testing would not be available, impacting product release and compliance.
Job Responsibilities
- Perform Analytical Method Validation (AMV) for injectable products as per regulatory guidelines.
Prepare and review AMV protocols and reports.
Ensure compliance with cGMP and regulatory standards during validation activities.
- Coordinate with QA and R&D; for method transfer and troubleshooting.
*Maintain documentation and ensure readiness for audits.