Sr. Executive - Quality Assurance (AQA) API Plant

Job Description

1. Responsible for review of QC Analytical Data for accuracy and adequacy. 2. Responsible for review of Raw Materials, In-Process, Intermediate, Recovered Solvents and Finished Products related data and documentation. 3. Responsible for review of all Analytical Method Transfer” related documents from ARD, Contract Giver to QC Lab. 4. Responsible for review of all Analytical Method Validations Protocol/Report of all APIs, Key Raw Materials and Intermediates. 5. Responsible to ensure the Analytical Method Validations of all APIs, Key Raw Materials and Intermediates are performed as per current version of SOP/current guidelines in Analytical Research Department (ARD). 6. Responsible for reviewing all “Working Standard Qualification” and related documents with respect to its accuracy and adequacy. 7. Review of all QC Instrument Qualifications/Re-Qualifications and its supporting data. 8. Responsible for review of all instrument calibrations w.r.t its accuracy and to ensure completion within stipulated timeframe. 9. Responsible for review of all specifications, standard testing procedures and related change controls for accuracy and adequacy. 10. Responsible to review of all “Laboratory Investigations” and OOS/OOT data. 11. Review Stability and holding time Planner. 12. Review stability and holding time data. 13. Review of DI Water, Drinking Water, Raw Water, RO-I Water, RO-II Water, Soft Water, Air monitoring Data. Requirements: Minimum of 6 years of experience in Quality Assurance in the API industry, with a focus on Quality Assurance & AQA Also Strong knowledge of regulatory requirements, such as EDQM, USFDA, WHO, and ICH guidelines. Proven track record of successfully implementing and maintaining QMS in an API company. Experience leading and managing a team of Quality Assurance. Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues. Excellent communication and interpersonal skills, with the ability to interact effectively with cross-functional teams. Attention to detail and a commitment to quality.