General Manager QA -API

• Responsible for Defining and Implementation of Quality Management system and Quality Assurance processes across Rudrapur (Tablets) and CMO/ CRO locations. • Ensuring compliance with all cGMP requirements in line with global and Indian regulatory requirements • Handling all Regulatory audits, Client Audits, Internal Audits • Responsible for Qualification /Audit of CxP Vendors and CxP service providers • Responsible for GxP Training • Responsible for providing all documentation and other necesary support for Regulatory for product registrations and life cycle management • Responsible for providing all documentation and other necessary support for Business / Marketing, Customers • Responsible for management of Deviations, OOS, Complaints, Changes, Qualifications, Validations • Responsible for Licenses, Certifications and compliance (Indian FDA / CDSCO)