1. Preparation, Review and effective implementation of Sop on SOP.
2. To prepare, review and get approval of BMR, BPR in coordination with IPQA and production team.
3. To review all the documentation related to regulatory submission and submit to regulatory department.
4. Planning and work distribution on daily basis.
5. To review all the Quality control related SOP, Specification, STP, GTP and worksheets for their compliance as per SOP, cGMP and respective regulatory requirements before final submission to RA.
6. To perform Gap analysis at regular interval to identify any gaps in quality system with respect to change in SOP, Updation in pharmacopeia, change in any regulatory guidelines etc, and to inform Head QA or his designee. To prepare & implement action plan as per guidance of Head QA.
7. To establish good documentation and filing system for easy retrieval & maintenance of all quality records.
8. To coordinate with purchase department for vendor qualification procedure and to maintain all required records/reports for the same. This also includes qualification of outside testing facility. To ensure that requalification procedure is also done as per schedule.
9. To coordinate with commercial department for applying for various product/manufacturing permission/ license from DCGI or local FDA. To maintain updated all such permission / license list at plant.
10. To coordinate with corporate ERP team for validation & effective implementation of ERP system at plant.
11. To prepare and maintain the department in compliance state.
12. Review and response to plant related regulatory queries within stipulated time period.
13. Training and development of plant compliance team.
14. To highlight/report/bring notice for any deviation/failure/non compliance in any of the work area to Head - QA or his designee.
15. To ensure implementation of organization policy and discipline in working area.