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.
Job Title
Section In-charge / Lead - IPQA