Officer-QA

Implement Operate monitor and maintain Quality Systems which enable operations on site to occur in an efficient manner and in compliance with Global Quality Standards and cGMPs.

Review and ARchival of Quality System Documents

Followup for timely closure of QMS docs

Participating in the investigations analysis for Deviations, OOS, OOT, Compliants and Audit finding, morevoer responsible for providing batch disposition as per the outcome of Deviation, OOS and OOT investigations

Supporting in external audits preparations and responding to audit findings

Compliation of the Internal Audit response and follow up

Assist in scheduling and preparation of management review meetings

Organize the CAPA meeting, coordinate amange CAPA efforts and interact with customers to conduct compliant investigations

Handling of Change Management CAPA Management System

Assist to author, review and update quality procedures as applicable

Responsible for Handling of Compliants, Mock recall/ Recall and withdrawal of Drug Products

Retentions Sample Management

Preparations of APR / PQR

Full time