Santosh Kumar

Experience

• 

  Quintiles

  Feb 2014 - Aug 2017

  Part of the QA Leadership team directly reporting to Senior Director QA. Responsible for handling the QA activities as and when assigned by the Senior Management.• Provide Support in hosting Customer audits/assisting the lead Auditors in preparation of Regulatory Inspections• Serve as a liaison between the Customer auditors and Operation staff, respond to queries of sponsor auditors, and provide the audit documents to auditors before and during the audits.• Generate metrics from the Quality systems, analyze and submit them to senior management.• Assist lead Auditors during the internal audits in reviewing the data, study documents etc.Verifying the auditee’s compliance with respect to SOP’s, Work instructions, Trainings andmaintenance of CV’s on the systems.• Archival and retrieval of study related documents and other necessary documents in the QA filingsystems • Document control Show less Part of the QA Database Metrics team. Responsible for tracking audits, follow up with respective action owners for CAPA implementation, generation of metrics on monthly, Quarterly, biannual and Annual basis, support auditors in drafting audit plans, arrange and participate in Senior Management QA meetings, attend to and submit the audit document requests.• Responsible for thorough update of Quality database for Audits, Quality Check of the data indatabase, Attending calls along with Project teams on status of audits, CAPA generation, Generation of Reports as per Customer needs etc.• Responsible for monitoring and maintaining Quality and Compliance targets in Quality Systems.• Monitoring & Tracking of the Past and future audits; Notifying Concerned project teams ofUpcoming Customer Audits and Regulatory Inspections.• Thorough follow up with Project teams of Audit reports and CAPA for the Issues raised duringAudits.• Attending Calls on a monthly basis to ensure timely Implementation of CAPA along with Auditors.• Delivering Monthly, Quarterly, Biannual and Yearly Metric reports to senior management.• Making sure that all QA records, data and information in database are updated thoroughly.• Coordinating with the team in achieving the set targets• Supporting Auditors in drafting Audit plans for planned Audits.• Generating Ad-hoc metric reports as per Customer Requirements. Show less

  • Quality Assurance Coordinator

    Jan 2016 - Aug 2017

  • Quality Assurance Associate

    Feb 2014 - Dec 2015
• 

  Chiltern

  Sept 2017 - Jan 2019

  Quality Assurance Auditor

  Conduct internal audits for Data Management and Pharmacovigilance and Clinical operationsHost customer audits Assist Operations in performing the RCA for findings/issues identified, review the CAPA and evidences and follow up till closureDocument Management, Change Management

• 

  Covance

  Jan 2019 - Feb 2020

  Quality Assurance Auditor
• 

  Qinecsa Solutions

  Feb 2020 - Jan 2024

  Manage and host client audits, Ensure internal standards are in conformity with applicable regulationsConduct internal audits of company policies and proceduresConduct audits of any vendors utilized to conduct business.Identify compliance gaps and provide support and suggestions for remediation.Facilitate the identification and development of Standard Operating ProceduresProvide training and guidance to staff regarding compliance and interpretation of SOPs/WIs.Participate in the development and maintenance of quality systems and process improvementsLead and investigate quality issues and implementing corrective and preventative actions; identifyingdepartmental strengths and weaknessesSupport the development and implementation of proper document management and change controlprocessesMentor team members by coaching and counseling staffTrain new hires on company processes and responsibilities Show less

  • Quality Assurance Lead

    Jan 2023 - Jan 2024

  • Senior Quality Assurance Analyst

    Feb 2020 - Apr 2023
• 

  IQVIA

  Jan 2024 - now

  Senior Quality Assurance Auditor