Roles & Responsibilities Review of qualification protocols and reports of facility, area, equipment, and utilities including URS, DQ/FS, RA, SLIA, Project specific qualification plan, commissioning checklist, IQ, OQ, UTM, PQ & RQ. Review and approval of smoke study protocol & report. Review of VMP and their subsequent revisions. Review of VMP re-qualification calendar for all equipment, facility, Utility etc. Review of PMP check list/schedules and Master calibration and Facility maintenance planner etc. Review of Audit trails, master instruments calibration certificates. Review of logbooks for its compliance and good documentation practices. Ensuring compliance to VMP revalidation schedule as per revalidation matrix for all equipment, facility, utility etc. Allotment of numbering for equipment’s, area, layouts and to prepare / Update the List. Handling and closure of quality management system which includes change controls, incidents & CAPA. Participation in investigations that are triggered due to incidents/deviations as applicable. Responsible for preparation, review of SOP as per requirement. Review of BMS & EMS related documents and alarms & audit trials reports for its compliance. Review of activity related to critical equipment breakdown notification. Review of equipment breakdown and general maintenance notification. Compilation and Preparation of Annual review of utilities reports. To perform GEMBA walk in utility system i.e.  HVAC, compressed air, and water system, etc. Review of Pure steam quality reports, compressed air and nitrogen gas testing reports. Review of documents in DocHub, e-VAL, SAP DocuSign as applicable. Review of cleaning validation protocols and reports. "