Leading the QMS, audit compliance and documentation team.
Work allotment to QMS team and monitoring of its completion and closer within stipulated time.
Responsible for effective compliance of the QMS system (Change Control system, Deviations, Incident, OOS and OOT etc) as per SOP, cGMP and international regulatory requirement in the plant.
Responsible for the compliance of Investigation, Root cause and Implementation/monitoring of proposed CAPA with concern team.
Responsible for the investigation of market complaints, product recall and its compliances.
Responsible for review of SOPs of quality assurance department as well as other departments and its approval.
Preparation/Review of the various compliance reports in regards of site inspection i.e. customer/ regulatory.
Responsible for review of master BMR, BPR & MFR.
Co-ordination for introducing new product in the plant and data review for regulatory filing.
Responsible for execution of self-inspection and monitoring of data integrity policy.
To impart the event based or as per plan training to the personnel and effectiveness monitoring.
Monitoring of plant activities with respect to cGMP compliance.
Review of raw material, packing material, and finished product specifications.
Handling of vendor qualification and related data review.
Ensure the compliance of vendor audit and approval of contract laboratory.
Responsible for the approval and release of the Batch.
Responsible for document control.
Responsible for the review and approval of stability protocol and report.
Review of various cGMP trend data i.e. CAPA, deviation, incident, OOS, market complaint and others.
Leading into failure investigations, impact assessment and monitoring of CAPA effectiveness.
To accept any additional responsibility as assigned by Head QA.
Responsible for approval of QMS document in the absence of head-QA.