Senior Executive or Executive (QMS) Special in Artwork

Requirements

New product development, initiation of artworks, approved and preparation of MFR/MMD. Review of stability report received from Quality Control to ensure compliance as per predetermined specifications specifically. Handling of RA related queries. To assist in investigation of market complaints, OOS and OOT. Updation and retrieval of Master MRP List.

Final release of finished Goods in absence of Head-QA. Handling of hold time study. Execution, verification and assistance of various validation activities like process validation, cleaning validation, HVAC validation, water validation, compressed air validation, Equipment qualification in absence of a concerned person.

To take facility rounds time to time to ensure compliance of cGMP. Planning and execution of internal audit as per schedule. Handling PQS including Change control management, Quality risk management, Deviation investigations, Incidents, Market complaints, CAPA and also maintain track of CAPA, trend analysis of deviations, Market complaints/OOS/OOT etc.

in the absence of a concerned person. Handling of Annual Product Quality Review in the absence of a concerned person. Approval of shade cards. Officer QA will look after the above mentioned responsibility in absence of Executive QA. Any other job as and when assigned by Manager-QA