RM/PM - Ensure receiving, storage, approval, rejection, dispensing of incoming material as per cGMP norms and defined procedures.
Equipment - Ensure manufacturing of products by using qualified equipment and as per cGMP norms and defined procedures.
Documentation - Responsible for Reviews and timely submission of various documents (BMR , BPR etc.) for filing.
Annual Product Reviews - Ensure preparation and approval of Annual product reviews
Master File - Responsible for approval of site master file
In process - Ensure compliance of In process checks, sampling and daily monitoring records
Change Control - Ensure timely completion of Change Control, deviations, OOS, incidents, market complaints, CAPA etc
Validation - To ensure availability of approved process validation protocols, cleaning validation protocols before execution, To ensure qualification of equipment, instruments, facility, utilities before usage.
Finished Goods - To ensure dispatch of products as per cGMP norms and defined procedures. Release of finished products.
Compliance - To ensure compliance to the regulatory and customer audits and respective recommendations.
