Executive Manufacturing QMS and compliance Injectable
AmnealAhmedabad, Gujarat, India
Posted June 4, 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
This role involves preparing and reviewing master documents for sterile manufacturing, protocol development, and management of documents. It includes handling of change control, investigations, training of personnel, and audit/compliance ensuring compliance with regulations. The position requires a knowledge of continuous improvement principles (kaizen).
Requirements
- Prepare and review master documents for sterile manufacturing.
- Prepare and review protocols and reports.
- Manage document management and preparation (BMR, BPR, SOPs).
- Handle change control, deviations, CAPA, and investigations.
- Train subordinates, technicians, and operators.