Prepare & execute quality manual along with CQA manager for corporate functions which needs to be followed at all sites.
Perform the common vendor audit as per the schedule in coordination with th CQA manager & site QA for Raw materials, intermediates , packaging material required for API Synthetic, API Biotech & Formulation plant.
Perform audit at all sites majorly related to QC as per schedule defined to meet ICH Q9, WHO, USFDA, MHRA, PIC/S etc requirements.
Review of sampling activity and guide the chemist to follow the correct procedure during routine, PV & CV activity.
Review of analytical method validation documents before being transferred to site from ADL. Review of specification & method of analysis to be performed prior to method transfer & coordinate with site QC manager for requirements as per specifications.
Review software details as per 21CFR requirements for all instruments. Coordinate with team leaders to complete gap analysis within stipulated time. Review of audit trail data taken for each instrument.
Review trends of purified water, environmental monitoring, etc.
Review of calibration,qualification & preventive maintenance procedure in QC.
Review DMF & dossiers prepared by Regulatory dept.
Review of OOS & OOT.
Review all technology transfer documents submitted by R & D.