Responsible for initiation of Change control Deviation Incident and CAPA. • Responsible for Management of Deviations. • Responsible for Management of Incidents. • Responsible for Management of Change Controls and accessing effectiveness of Change Control. • Responsible for Management of CAPAs and accessing effectiveness of CAPA. • Responsible for Investigation of Complaints Logging CAPA monitoring for Closure Archival. • Responsible for handling of Investigations. • Responsible for Preparation of Deviation Change Control Incidents Complain CAPA Investigation annual trends. • Responsible for preparation & review of Quality Risk Management. • Responsible for Co-ordination with all departments for QMS related activities. • Responsible for SOP preparation and review. • Responsible for collection of Manufacturing Packing QC Vendor QMS data for APQR preparation. • Archival of all APQR. • Responsible for Preparation of dispatch Documents. • Issuance of BMR BPR Analytical protocol formats logbooks. • Responsible for execution of self inspection activity conducting self inspection of inter department & maintenance of records. • To Prepare and review master documents such as Process validation Protocol packing validation Protocol Hold time study protocol cum report & Validation Master Plan. • Responsible for Preparation and review of master documents such as Equipment qualification protocol and review of executed Equipment qualification report. • Responsible for cleaning validation activities and documentation.
