Jignesh Khamkar

Experience

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  The Janssen Pharmaceutical Companies of Johnson & Johnson

  Sept 2014 - May 2019

  SPOC for Data Integrity, Audit trail and Computer system validation. Responsible for qualifying and validating lab instruments as per 21CFR part 11 and Annex 11 requirements. Accountable for planning calibration activities with service engineers for maintenance. Expertise in Change control for implementing instrument and software related changes. Responsible for Training service engineers and new joinees on cGMP requirements. Serve as a system admin for standalone instruments.Responsible for reviewing raw data of analysis and instruments challenging all aspects of data integrity and ensuring compliance with respect to SOP. Performing analysis of stability samples. Support in method transfer and validation related activities. Managing Inspection and ensure Inspection readiness of site Show less Project lead for Shipment excursion stability studies. Defined temperature range for more than 45 products in US and EU markets.Serving as a Quality function for Pilot Plant and engineering. Reviewing Master/ Batch documents, analytical reports, COA and other support documents for batch release. Approving protocols, validation plans and other documents related to pilot plant. Risk management. Performing check rounds and internal audits inorder to ensure Continuous process improvement. Co-ordinating with QP for batch documents and quarantined shipments. Ensuring regulatory compliance for the batches manufactured by reviewing BPR and dossiersHaving an oversite for calibration and maintenance related activities at the plant and laboratories.Ensuring that the sight is audit ready by challenging the status quo of the audit process. Handling Investigations, Deviations, Change controls and CAPA for manufacturing related activitiesConduct cGMP training for new joiners and refresher cGMP training for site Show less

  • Quality Control Officer

    Aug 2017 - May 2019

  • QA Associate

    Sept 2015 - Aug 2017

  • Trainee

    Sept 2014 - Aug 2015
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  Deloitte Touche Tohmatsu LLC

  May 2019 - Apr 2020

  Senior Executive

  Commercial Quality (Third Party Manufacturing and Business Quality)Managing CMO and ensuring compliance to the quality agreements. Tracking APR-PQR and stability reports. Tracking KPIs on periodic basis. Performing audits to ensure compliance to the local process and guidelines. Support in deviations, investigations and change controls. Managing CFAs, distributors and central warehouse. Ensuring compliance with respect to Quality agreements. Perform batch release and transactions with respect to saleable returns, stamping request. Responsible for deviations, CAPAs and change controls. Ensuring compliance with respect to Good distribution practices. Having quality oversite to NABL testing to support Institutional sales.Responsible for Quality Risk management and market complaints.Support in implementation of scientific systems on site Show less

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  Boehringer Ingelheim

  Apr 2020 - now

  Assistant Manager Commercial Quality

  Commercial Quality (Third Party Manufacturing and Business Quality)Managing CMO and ensuring compliance to the quality agreements. Tracking APR-PQR and stability reports. Tracking KPIs on periodic basis. Performing audits to ensure compliance to the local process and guidelines. Responsible for deviations and investigations.Responsible for Quality Management for more than 10 CFAs and 10 AH CMOsExpertise in Complaint Handling, Recall and Anti-counterfeit measuresSubject Matter Expert for Data Integrity, Quality Risk Management and Change ControlAccountable for Batch release, Market Returns and Re-packaging related activitiesResponsible for Quality Management Review and KPI trendingExpertise in Trackwise, SAP, Veeva vault, docspaceAccountable for maintenance of SOP and Quality Agreements Show less