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Teva Group Leader Quality Assurance India, Maharashtra, Navi Mumbai 869348606
05.05.2024
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How you’ll spend your day
- Ensure that the processes needed for Quality Management System are established, implemented and maintained at WPPL.
- Report on the performance of the quality system to the Head-QA for review and as a basis for improvement of the system.
- Plan and execute the clinical activities to ensure that all the data of the clinical phase is audited and check the compliance with the relevant SOP’s and current GCP/applicable GLP guidelines, protocols.
- Plan and execute general audits, system audits for all departments.
- Review equipment installation, qualification, calibration and preventive maintenance in clinical department and verify these activities are conducted as scheduled.
- Review of WinNonlin data, Pharmacokinetic analysis and statistical output of clinical study, clinical study reports as per the requirement.
- Review of statistical analysis data and statistical analysis report of In-Vitro Binding Study
- Conduct external vendor audits.
- Review the raw data of clinical projects as and when assigned.
- Conduct internal study audit, and system audits to check compliance with GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
- Review Change Control and evaluate its impact.
- Review deviation and CAPA's and evaluate its impact.
- Conduct facility / risk-based assessment audit at clinical and pathology laboratory for BA/BE studies conducted at WPPL as and when directed.
- SDTM data review, verification and data flow from QA to SDTM team.
- Support Head-QA during regulatory and other inspections / audits at WPPL.
- Review the responses to regulatory and sponsor’s queries at WPPL.
- Ensure CAPA actions based on the results of the investigations are identified and implemented.
- To provide support to WTI group for audit of statistical data, clinical study reports as per business timelines
- Review / update periodically Policies, Quality Manual, Site Master File at WPPL.
- Review / update the SOPs and work documents at WPPL prior to their approval and give comments on the same.
- To conduct monitoring of studies at external CRO as per assignment.
- To carry out other responsibilities as and when assigned by the Head-QA.
- To sign as designee for Head-QA for all controlled documents’ if Head-QA is not available.
- To conduct meetings with clinical and pathology laboratory department to update on quality system.
Your experience and qualifications
- M.Sc, M.Pharm or Ph.D
- 8 -10 years of experience into Clinical Quality Assurance for BABE Studies
Reports To
- Associate Director Quality Function
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