Experience

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  Organon India Ltd

  • Mumbai, Maharashtra, India

  • Senior Specialist - Audit & Inspection Management

    • Feb 2023 - Present
    • Mumbai, Maharashtra, India

    • Facilitate on-site Audits and Health Authority inspections. Support the Global Audit and Inspection readiness program and CAPA management.• Responsible for the delivery of metrics for Key Quality & Compliance activities. Analyze and leverage quality indicators and data to identify potential trends and risks.• Support functional areas in assessment of potential root causes and remediation (CAPAs) and Effectiveness Checks.• Perform and report on Internal and External audits.• Lead or participate in co-audits with other QA auditors. Work with internal personnel to develop and execute strategic audit plans. Collect and review responses to audit observations and follow-up/escalate inadequate or delayed responses as necessary to ensure CAPA timelines are met and responses of satisfactory quality are obtained.• Provides Inspection management support.

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  Bioclinica

  • Mysore, Karnataka, India

  • Senior Manager - Quality Assurance & Regulatory Compliance

    • Nov 2021 - Feb 2023
    • Mysore, Karnataka, India

    • Schedule and conduct Internal PV audits, release audit reports, approve CAPA responses and track CAPA actions to closure.• Managing external client audits and monitoring compliance to the audit schedule.• Provide oversight for end-to-end PV CAPA & Deviation management process.• Audit/Findings/CAPA records management in EDMS.• Review CAPA plans, provide feedbacks on investigation, corrective action, preventive actions, and EC checks.• Manage, track CAPAs/Deviations/issues in compliance with the applicable procedural documents.• Publish monthly compliance dashboard related to CAPA/Audit Findings/Deviation deliverables.• Comply QMS procedures as per requirements specified in the Manual, applicable company policies and SOPs/SWIs/Guidance documents.• Review SOPs/WIs developed by the PV projects.

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  Tata Consultancy Services

  • Mumbai Area, India

  • Project Manager - Pharmacovigilance

    • Aug 2016 - Nov 2021
    • Mumbai Area, India

    • Support the continuing development and implementation of a process for managing/tracking CAPAs and deviations.• Coordinate with Client stakeholders for effective tracking of assigned CAPAs/Deviations.• Contribute to CAPA/Deviation Management implementation and documentation by completing all required processes.• End to End Audit/Findings/CAPA records management in TrackWise.• Ensure training compliance across project and robust training documentation.• Well versed with IQMS audits as an Auditee and Auditor (scheduling, conduct, release/draft audit report, approve CAPA responses & track CAPA actions till closure).• Publish monthly compliance dashboard related to CAPA/Findings/Deviation deliverables.• Supporting the Global QPPV office in managing the PSMF in line with the relevant Client processes by quality check of assigned PSMF Quality sections & respective annexes.

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  Crest Premedia Solutions Pvt Ltd

  • Pune Area, India

  • Team Lead - Quality Management System

    • Apr 2016 - Aug 2016
    • Pune Area, India

    •CAPA and deviation management.•Ensure that CAPA plans are effectively implemented, monitored and closed out.•Act as Compliance/safety lead for projects•Ensure maintenance of the QMS through the appropriate QMS Management review processes.•Prepare for Regulatory as well as client audit.•Auditing – Ensure a Local process is in place to support Audit activities as necessary, including Health Authorities Inspections.•Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with Compliance standards and Policies.•Communicate with Operations and clients to ensure compliance with Project SOPs and Regulatory guidelines.•Manage Local Training activities as necessary.

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  Sciformix Technologies Pvt Ltd

  • Pune Area, India

  • Lead Quality Specialist

    • Mar 2015 - Mar 2016
    • Pune Area, India

    •CAPA and Deviation management activities which include preparation, review, and coordination for appropriate and timely closures, with support from QA management as required.•Build, maintain and manage tracking mechanisms to ensure compliance in CAPA management of the assigned project/process.•Publish monthly compliance dashboard related to CAPA deliverables.•Responsible to coordinate and handle queries related to CAPA management during the respective Internal, Client or Regulatory audits/Inspections of the assigned projects.•Document change control/review/tracking and record management.•Assist in Audit readiness and support Internal/Client audits & Regulatory inspections.•Coordinate with Operations team in reviewing the training plan, identifying training needs, training related activities required for project including training documentation process, feedback mechanism and training file review activities on a regular basis.•Ensure training compliance across project and robust training documentation.

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  Accenture Services Pvt. Ltd.

  • Bangalore

  • Safety Surveillance Associate and DDQC associate

    • Jan 2012 - Mar 2015
    • Bangalore

    •Overall more than 3 years of experience as Subject Matter Expert in Accenture.•Coordination of training related activities for the project which includes training documentation, conducting/coordinating project related trainings, managing the documented evidences/records of trainings for the project.•Assist the team in managing the requests during the audits related to training management.•Highlight any issues related to training management.•Perform daily ICSR and source data review of the cases processed•Provide support required for Regulatory inspections and Internal & Client audits•Provide mentoring and refresher training for colleagues as necessary•Support internal quality improvement activities and perform all tasks as assigned by the DDQC lead•Develop and maintain expertise and knowledge of all assigned products within a therapeutic area; guidelines, SOPs and narrative writing practices; and case processing conventions•Mentor colleagues in area of expertise and perform peer review, when assigned

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  MMSH Clinical Research Pvt. Ltd.

  • Bangalore

  • Safety Narrative Writer

    • Dec 2010 - Jan 2012
    • Bangalore

    •Writing the safety narratives for adverse events which will then be appended in the clinical study reports for regulatory submission•Performing QC of the narratives which helps to increase the quality of the drafted narratives•Trained on MedDRA coding of the adverse events and serious adverse events•Participate in training programs and meetings to continuously improve the process

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  Excel Life sciences Pvt. Ltd.

  • Madgaon Area, India

  • Clinical Research Co-ordinator

    • Nov 2009 - Nov 2010
    • Madgaon Area, India

    •Ensuring the conduct of the trials as per the ICH GCP & Protocol Specified guidelines•Follow-up with site team for timely completion of the Source Documents and ensuring that all the relevant information required in the Case Record Form are present in the source document•Complete the Case Record Forms within the timelines and with minimal errors

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  Wyeth Ltd (Now Pfizer)

  • Verna, Goa

  • Executive IPQA & QC

    • Jun 2008 - Oct 2009
    • Verna, Goa

    •Analysis of raw material, bulk tablets and finished products using instruments like UV-visible spectrometer, High performance liquid chromatography and IR-instrument•In-process quality assurance of all pharmaceutical manufacturing activities