QA Documentation Officer

Issuance of Sop’s, formats, Logbooks, Specifications and other documents.

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.

Issuance and retrieval of BMR and BPR in absence of concerned person.

To maintain training documents.

Preparation, review and retrieval of Sop’s.

Updation of induction training record,certified training record,on job training and training need identification record.

Stability studies management including samples charging in chambers, samples withdrawn for analysis as per Schedule, Schedule preparation of new products and collection and review of stability data per, maintain protocols, maintain cleaning record of stability chambers and stability reports retrieval per station.

To maintain control sample room.

Daily monitoring of temperature and humidity of control sample room.

To maintain destruction record of control sample and also ensure the destruction of samples as per schedule.

Retrieval of specifications and Standard test procedures.

Updation of Equipment lists, Self inspection planners,Technical staff and Internal trainer list.

To maintain JD’s/ Signature log/ Organograms/ Layouts/ QTA/ Contracts etc.

Handling of RA related queries.

Execution and Maintain Compliance Reports /internal self inspection as per schedule under supervision of Manager-QA.

Approval of shade cards in absence of concerned person.

Executive will look after above mentioned responsibility in absence of Officer QA.

Any other job as and when assigned by Manager-QA