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.