1.Responsible for review and approval of all SOPs, protocols and master controlled documents. 2.Responsible for review and approval of all OOS, Deviation, Change Control, Market Complaint and product recall. 3.To represent company during external/regulatory audits. 4.Responsible for conducting self-inspection/ internal audit as per schedule. 5.To impart trainings on QMS, ISO and cGMP guidelines. 6.To represent company during external audits and provide closures of observations alongwith CAPA. 7.To review and approve all batch manufacturing and analytical records. 8.To monitor IPQA activities. 9.To report internal audit and external audit findings to top management alongwith proposed CAPA. 10.To ensure effective implementation of all SOPs and documents related to QMS in all departments. 11.To review and approve all new/revised artwork as per approved procedure. 12.To prepare QMS monthly report and submit to management. 13.To ensure that APQRs are prepared, reviewed and approved.