Sr. QMS Executive

6 days ago


Ahmedabad Bhopal, India E Friend Technologies Full time
QMS Sr. Executive 
Experience: 7-8 Years
Location: Bhopal

• Logging, review, evaluation and approval of process, facility, CAPA related change
controls in manual or online system .
• Review of process technology transfer documentation.
• Review of manufacturing investigation report and closure of investigation by putting
appropriate CAPA in place.
• Performing internal audits for ware house, manufacturing and engineering system.
• Evaluation of process validation protocol and defining validation strategy to maintain
validated status of the product.
• Review of process, facility deviations and ensuring adequate closure of those with
appropriate CAPA in place.
• Preparation and review of core QMS SOPs and policies.
• Review of manufacturing equipment and utility system qualification documents.
• Review of cleaning validation protocol and reports.
• Review of OOS, OOT, deviation, incident reports and participation in investigations.
• Review of manufacturing batch release documentation.
• Maintenance Product, water system quality trend and general system trend
maintenance.
• Review of manufacturing system batch wise audit trail review for each batch release.
• Manufacturing incident investigation and closure of incidents.
• Logging of out of specification results and taking part in investigation.
• Preparation of quality matrix report for monthly submission to regulatory authority
• Handling regulatory inspections as a SME for QMS system.
• Review batch and periodical cleaning records for its adequacy and completeness.
• Review and approval of preventive maintenance and executed preventive
maintenance records and engineering warehouse record.
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