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
