Senior Project Manager- Biostudies

• May 2022 - Present

Project Manager-Biostudies

• Oct 2018 - May 2022

Associate Manager-QA

• Mar 2016 - May 2022

 Develop and maintain a Quality Management System involving writing, review and implementation/ training of Standard Operating Procedures and guideline work instructions to all departments to ensure compliance with GCP and country specific regulatory requirements under the direction of Head of Quality Assurance Design & implement audit and assessment methods to measure compliance, perform internal and external audits of clinical activities ensuring compliance to regulatory standard guidelinesAudit of all aspects of clinical research studies protocol compliance Clinical data, planning and conduct of clinical studies, Clinical reports, Pharmacokinetic reports and study reports in compliance with FDA, ICH GCP, ANVISA, and EU Conduct induction/orientation of new staff in quality policies and procedures Follow up all audit reports for completion of corrective and preventative actions (CAPA) and timely closure of the audit reports Liaison between staff and external agencies during regulatory inspections or Sponsors Due Diligence Visits and Study Audits Show less

Senior Executive-Quality Assurance

• Apr 2014 - Mar 2016

As a lead QA, ensure that SOPs are current as per the regulatory requirements. Responsible for identifying gaps in the identified function and proposing requirements to the management Prepare and review comprehensive audit reports and communicate audit findings from audits to management ,department heads and auditees as appropriate Follow up all audit reports for completion of corrective and preventative actions (CAPA) and timely closure of the audit reports Provide department heads with reports, assessing root causes and compliance feedback, and including follow-up actions Conduct trend analysis of issues identified during internal audits across the organization and share with the teams Conduct audits of vendors when key processes are outsourced to third parties .. Provide technical and regulatory expertise in the development and application of procedures, training materials, communications, and/or tools. Show less

Senior Executive-Quality Assurance

• Nov 2010 - Mar 2014

 Perform internal audits for Clinical Operations with an objective for determining the compliance of Essential Documents, Trial Master File/project files, Clinical Project Plan, etc. on a random sampling basis or 100% basis with respect to approved procedures and applicable statutory requirements.  Perform regular facility and clinical study inspection of clinics and report findings to respective heads.  Identify and mange quality issues, assist operations in corrective action plans preparation and implementation.  Perform trend analysis of quality related observations and drive training to prevent recurrence  Review Standard Operating Procedures for all departments during initial development, preparation and revisions  Audit of all aspects of clinical research studies protocol compliance Clinical data, planning and conduct of clinical studies, Clinical reports, Pharmacokinetic reports and study reports in compliance with FDA, ICH GCP, ANVISA, and EU  Conduct internal process audits and external site audits to assess compliance with SOPs, GCP and other regulatory requirements.  Conduct quality reviews of protocols, CRFs, Clinical study reports and supplemental study documentation.  Handling and facilitation of regulatory, consultancy and sponsor audits.  Liaison between staff and external agencies during regulatory inspections or Sponsors Due Diligence Visits and Study Audits  As an auditor, perform the duties assigned in an efficient and effective manner. This includes liaison with the sponsors on all QA issues, including audit planning and review of audit results  Follow up all audit reports for completion of corrective and preventative actions (CAPA) and timely closure of the audit reports  Ensure timely Metrics Reporting to key internal and external stakeholders and flag defects and process change needs to senior management Show less

TEAM LEAD-QUALITY CONTROL

• Sep 2007 - Nov 2010

  Leading the team of Quality Control Associates towards proper execution of all audits - internal, in process, retrospective audit, document in accordance with SOPs and ensure compliance to ICH GCP guide lines.  Accompanying clients during their visit / Audit.  Coordinating for the regulatory audits.  Conduct Feasibility and providing synopsis.  Tracing project time lines & ensuring the timely delivery of project reports.  Overseeing the clinical supply management and coordinating with store persons and helping out to find out the procurement of Lab instruments.  Constant interaction with clients regarding the study and updating the status.  Identifying the investigators for patient based studies.  Continued maintenance of a clinical QC System with written standard operating procedures (SOPs)  Preparation of quality Control department SOPs  Conduct of quality reviews of protocols, CRFs and supplemental study documentation  Conduct internal process audits and external site audits to assess compliance with SOPs, GCP and regulatory requirements  Performing additional responsibilities assigned by unit head  To carry out QC checks of various phases of BA/BE studies as per SOPs and Protocols and report to Unit head  Review of ICF and Protocol before submission to IEC & review of IEC approval process  Checking of study requirements before starting the study  Checking check-in, dosing, blood sample collection and sample separation  Verification of study file, essential documents, clinical updates, raw data and study report for data accuracy  Checking all log books related to project for completeness and correctness of entries  Responsible for verification of study related documents for archival Show less