Team Member - QA Validation

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.
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Function: Other
Experience Level: Mid-Senior Level