Group Leader Quality Assurance (BA/BE Studies)

Role & responsibilities :

• 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 SOPs 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.