Raghavendra V

Experience

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  Piramal Group

  Mar 2008 - Aug 2010

  Research Associate-QA

  Plan, prepare, conduct and report the audits of regulated activities related to BA/BE studies in accordance with the Protocol, verifying compliance with GxP guidelines/regulation, in timely manner. Review protocol raw data and final report for accuracy, consistency and compliance. To review and audit the final report of BA/BE studies for submission to respective regulatory bodies in accordance with regulatory requirements. To carrying out in process and system/internal audits to ensure compliance BA/BE center. Perform quality review of documents (e.g. clinical trial reports, protocols, informed consent documents) to ensure accuracy, completeness, consistency and compliance with regulatory requirements. Independently review quality and compliance criteria adherence for a study protocol/ individual study trial. Review SOPs, Formats and Lab note books for compliance with principles of GCP and GLP pertaining to Clinical studies and Bioanalytical studies. Retrospective Audit of Bioanalytical/ Clinical / PK phase activity such as Bioanalytical Study data, Method validation data, Bioanalytical Report, calibration/Qualification/Validation data of all Instrument and Software. Review and management of QMS tool such as Deviation, Investigation, CAPA Implementation, change control system, risk management and system document management. Management of quality related document and effective archival system. Develop training program and provide training to staff to enhance workplace performance at all levels of staffing. Support the development and implementation of a Clinical quality work. To assist regulatory inspector/sponsor during regulatory inspection and Sponsor audit. Show less

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  Aurigene Discovery Technologies

  Aug 2010 - Jul 2016

  Plan, prepare, conduct and report the audits of regulated activities related to Non-clinical safety studies in accordance with the Study Plan, verifying compliance with GLP guidelines/regulations and ad hoc as assigned, in timely manner. Evaluated audit responses to ensure that all findings had been satisfactorily addressed. Retrospective/Process based audit of Bioanalytical/Analytical/ Non clinical / PK phase activity such as Bioanalytical Study data, Method validation data, Bioanalytical Report, calibration/Qualification/Validation data of all Instrument and Software. Author, revise, update and implement of QA SOPs and provide recommendations on SOPs, Work Instructions for other departments. Review of SOPs, Formats and Lab note books related to all functional department of discovery and nonclinical. Communicate to management any critical or compromising audit finding in a timely and expert manner. Actively participate in key internal project team meetings and facilitate quality discussion during study plan meetings. Management of quality related document and effective archival system. Participation in instrument/equipment /facility qualification activities. Implementation of Quality system and maintenance of documents in compliance with GLP. Debrief audits and ensure issuance of CAPA plans and close-out of corrective and preventive actions according to the CAPA and standards expected. Evaluate corrective and preventative actions (CAPA) plans to ensure implementation and to determine effectiveness. Review and management of QMS tool such as Deviation, Investigation, CAPA Implementation, change control system, risk management and system document management. Conduct training for GLP compliance and Quality Assurance activities. To assist regulatory inspector/sponsor during regulatory inspection and Sponsor audit. To perform vendor audit and in assessment of Vendors/suppliers along with the Functional Group Support the management on quality issues or deviation Show less

  • Senior Executive 2-QA

    Apr 2013 - Jul 2016

  • Senior Executive 1-QA

    Sept 2011 - Mar 2013

  • Research Associate-QA

    Aug 2010 - Aug 2011
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  Sai Life Sciences Ltd

  Sept 2016 - Jan 2017

  Deputy Manager-QA
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  GVK BIO

  Jan 2017 - Mar 2021

  Deputy Manager-QA
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  Aragen Life Sciences

  Apr 2021 - Dec 2023

  • Corporate Quality Assurance-Manager

    Oct 2022 - Dec 2023

  • Manager - QA

    Apr 2021 - Oct 2022
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  Bristol Myers Squibb

  Dec 2023 - now

  Quality and Lab Compliance

  Develop, implement, and maintain quality system documentation (SOPs, WIs, templates, forms) adhering to QMS requirements and regulations (GCP, Translational Medicine, 21 CFR 820, GLP, GCP, ISO 13485) and CLIA/CAP lab operations.Implementing EDMS platform in the Translational Medicine department. Conduct a thorough gap analysis, meticulously comparing product standards against current QMS requirements. Identify discrepancies and develop a roadmap for implementing necessary process engineering changes.Conduct internal audits and inspections to assess quality procedure compliance and identify improvement opportunities.Identify potential impacts to project timelines proactively as a result of audits and review and work with necessary cross functional team(s) as appropriate to develop resolution plans and implement accordingly.Investigate and respond to Corrective and Preventive Action (CAPA) and work with Operations to obtain evidence of deliverables and facilitate effectiveness checks as needed to ensure CAPA closure. Assist in the preparation, execution, as well as the drafting and tracking of responses to external audits and inspections. Identify areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate QA staff. Assists in development and modification of departmental work instructions and collaborates with appropriate R&D staff to ensure alignment with SOPs.Maintain thorough and current knowledge and understanding of GCP, ICH and GLP regulations associated with the maintenance and retention of clinical trial documentation. Act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as required.Participate in external & internal audit.Oversee data collection and analysis for Quality KPIs, preparing reports to monitor quality trends.Maintain up-to-date knowledge on Clinical Trials regulations (GCP, 21 CFR 820,) and update quality documentation accordingly. Show less