Job Description
1. Responsible for supporting the Development Quality Assurance team, for the Research and Development activities at RD level.
2. Review of Development documents and process for IND, NDA, and ANDA including Analytical Methods and PDR.
3. Implement the Development Quality System based on Quality by Design concept.
4. Develop, implement, track, review, approve elements of the Quality Management System including but not limited to SOPs, Change Control, Deviations, Incidents, CAPAs and Product Complaints.
5. Facilitate for performing Risk Assessment and monitoring of proposed mitigation plans.
6. Product Development Report complete review and approval along with concern QbD elements.
7. Responsible for implementation of QbD tools wherever feasible in product development process.
8. Conduct periodic internal audits to ensure that compliance procedures.
9. Handling the quality system documents like Change control, Deviation and Incidents in R D Center as well as which are taken in Contract manufacturing Organization.
10. Conducting out-sourcing facility audit, vendor evaluation and finalize the vendors for all API, Excipient and packing materials as per current regulatory requirements to augment Quality management system.
11. Training, guiding and motivating team to enable most efficient delivery with defined quality compliance system.
12. Conducting the system improvement secession with other department heads.
13. Responsible for review of RD lab notebook/lab trial review.
14. To verify the activities as being performed as per cGMP and GLP.
15. Responsible for preparation/review of exhibit batch MFR and MPR.
16. Responsible for review of stability study protocol at RD level.
17. Co-ordinate between RD and RA department for document filing. Providing end to end support for regulatory submissions of ANDA s and its deficiency response.
18. Controlling BA - IVRT study
19. Review of audit trails and holding admin responsibilities for all software
20. Review and approval of all data which is require by RA including Electronic signatures for chromatographic data.
21. Sample management and keeping control on same through proper documentation system.
22. Qualification of instruments, equipment s, lab and R and D area as per guidelines.
23. Review of regulatory responses and contribution in finalising responses.
24. CSV (Computer System Validation)
25. Data archival, retrieval and storage with proper tracking system.
26. Any other duties as per organizational requirements.
No Referrers Available
There are currently no referrers available for this job. You can still apply, will let you know once there is any referrer available.