Tarun Batra

Experience

• 

  Apothecaries Pvt Ltd

  Sept 2008 - May 2011

  Executive Quality Assurance

  • Accountable for revision and maintenance of quality manual of QA department • Handled the preparation organizational SOP’s, evaluation, distribution and withdrawal of SOPs • Carried out Induction Training for new joiners• Organized GCP, SOP and Study Specific Trainings for study staff, prepared individual training records/file • Efficiently supported & performed Audit for clinical trials/studies • Performed the following:o Internal as well as External Site Audits for ascertainment of sponsor SOPs and applicable regulatory requirementso System Audit of drug store facility and archival facility as per predefined schedule or as applicable• Offered guidance and training on GCP compliance issues• Forwarded monthly report to the senior management that focused on matters that required attention Show less

• 

  CHRD SAS

  May 2011 - Dec 2018

  Quality Assurance Manager

  • Accredited for setting-up the Quality Assurance division from scratch• Manage and drive all operational aspects of the quality assurance department • Introduction of SOPs• Lead, coach, train, and mentor assigned quality assurance personnel• Develop and maintain the Company’s quality management system (QMS)• Ensure that all company personnel are trained and understand their responsibilities with respect to the QMS• Prepare and maintain all quality related documentation to include but not limited to standard operating procedures (SOPs) in support of the QMS• Develop and deliver company-wide effective training on the QMS and SOPs. Provide daily oversight of the company’s QMS and notify applicable supervision/management of unauthorized deviations. • Responsible for establishing quality goals and objectives and for establishing appropriate performance metrics to monitor for trends requiring analysis and corrective action• Host government regulatory, sponsor, and third party audits • Problem solving: collecting information before making decisions; weighing alternatives against objectives and making reasonable decisions• Prepare department budgets, track budget status regularly and make course corrections as necessary• Excellent leadership and management abilities. • Solid independent thinking ability and demonstrated ability to discern multiple viewpoints. • Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc. • Demonstrated ability to conduct root cause analysis and to prepare written remediation plans. • Demonstrated process auditing and improvement skills and aptitude. • Ability to effectively train and educate internal staff on procedures and regulatory issues. • Demonstrated ability to develop effective procedures and to write clear, consistent, thorough SOPs.• Excellent verbal and written communication skills. Show less

• 

  Tech Observer

  Dec 2018 - now

  • Associate Director QA

    Apr 2024 - now

  • Sr. Manager QA & SQM

    Feb 2021 - Nov 2024

  • Quality Assurance Manager

    Dec 2018 - Mar 2022