Assistant Manager Qms
Current• Achieving timely and effective investigation for Out of Specification (OOS) , Out of trend(OOT),Incident along appropriate root cause analysis for Quality control department.• Responsible for Handling of Deviation and Change management associated with Quality control department through QMS software and achieved about 85% efficiency of closing of QMS document within predefined timeline.• To ensure that all activity related Vendor qualification and Batch Released are completed in… Show more • Achieving timely and effective investigation for Out of Specification (OOS) , Out of trend(OOT),Incident along appropriate root cause analysis for Quality control department.• Responsible for Handling of Deviation and Change management associated with Quality control department through QMS software and achieved about 85% efficiency of closing of QMS document within predefined timeline.• To ensure that all activity related Vendor qualification and Batch Released are completed in timely manner . Review of protocol and report for stability study & other product development studies• As a part of continues improvement system, implementation of effective CAPA to further reduce non-conformance in Quality control department by about 20% on yearly basis• Associated with Regulatory audit compliance team for delivering effective and timely compliance as per regulatory requirement.• Investigate market/ customer complaints and close it with proper CAPA• To review and Identify Gaps in standard operating procedure (SOPs) ,specifications ,MOA through DMS software and timely updation of the same as per requirements.• Periodically perform internal Audit and carry out Internal quality compliance Training .• To ensure that all activity related to Batch Released are completed in timely manner through LIMS Show less
