Expert knowledge of GMPs, regulations and validation methods.
Expert in Good Documentation.
Demonstrated knowledge and application of QSR, Medical Device Directive, ISO 9001, ISO 9002, ISO 13485. ISO 11137, ISO 11138 and other international standards.
Knowledge of applicable laws and regulations.
Working experience with Local FDA, CDSCO, DCGI New Delhi.
Expert in FDA documentation for getting approval/license i.e. Form-41, Form-10, Form-28, Free Sale Certificate, Loan License, WHO-GMP, Additional Product, Performance & Non-Conviction Certificate, GLP, COPPs.
Knowledge of scientific, legal and business issues to ensure in order to control the safety and efficacy of the products.
8. Candidates should be Science Graduate, Post Graduate in Pharmacy, Biological Sciences or Chemistry.
9. Should have Min. 12-15 years of experience in QC or QA functions in Medical Device or Pharmaceutical Industry.
10. Willing to relocate Vadodara