Deputy Manager, QA Validation
AmnealAhmedabad, Gujarat, India
Posted May 10, 2025
Full Time
About the Company
Amneal is a dynamic pharmaceutical company focused on delivering affordable access to essential medicines. With a robust generics business and growing portfolios in injectables, biosimilars, and international markets, Amneal invests in scientific rigor, production capabilities, and employee well-being to enhance its value proposition.
Job Description
The Deputy Manager of Quality Validation is responsible for ensuring qualification and validation of equipment, systems, and facilities. This role involves reviewing documents, preparing reports, coordinating with personnel, and ensuring adherence to quality control standards. The position requires strong organizational and communication skills and a focus on GMP compliance.
Requirements
- Review URS, DQ, and vendor documents.
- Prepare and review Validation/ Qualification protocols.
- Execute and review Qualification/ Re-Qualification and Validation activity.
- Coordinate with manufacturing, Engineering, and QC.
- Prepare media fill/hold time protocol.
- Prepare Standard Operating Procedures (SOPs) of the Quality Assurance Department.
- Conduct sampling and assess change control, deviation, CAPA, investigation.
- Prepare process validation and cleaning verification protocols.
- Monitor cGMP compliance at shop floor.
