About this role
Role Overview
- Managing and handling audits (Internal, Customer, Regulatory and Certification Body).
- Part of Quality improvement team and compliance to ensure system development.
- Managing and maintaining all validation document and lifecycle at facility.
- Assurance of quality matrix of the Ahmedabad site by assuring the quality management system like Management of Change controls, Management of Market complaint, Deviation Management, OOS management are been done per the defined process work flow.
- Management of all CAPA for internal and external audit, including CAPA taken against any investigation with tracking, effectiveness verification and closure.
- Preparing and compiling Quality Matrix Monthly/Quarterly/Half yearly and Annual.
- Responsible for batch release of finished products.
- Responsible for ISO, NABL, FSSC2200, EXCiPACT training and certification.
- Responsible for Vendor audit for RM and PM and New PM vendor development process
Requirements
- Education: B.Pharma/M.Pharma, MSc. Chemistry, Btech or Mtech with biotechnology or chemistry.
- Experience: 10-15 Years of experience in Pharmaceutical, API or excipient regulated industries in different regulated markets like US, Europe & China.
- Supervisory Responsibilities: Yes
Benefits
- Comprehensive benefits package
- Opportunities for challenge and growth