Bioanalytical QA Auditor 1 1

Job Description

• Should be able to perform project specfic bioanalytical, pharmacokinetic (PK), statistical processes and data audits as per the QA SOPs and audit programmes to ensure compliance with inhouse bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidances as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit.

• Should be able to perform audits and review of processess, raw data and documents including SOPs of bioanalytical method development, method validation, study sample analysis & reports to ensure the compliance as per the applicable regulatory guidance and inhouse bioanalytical SOPs.

• Should be able to perform audits and review of processess, raw data and documents including SOPs of pharmacokinetic/statistical data management, analysis & reports to ensure the compliance as per the applicable regulatory guidance and inhouse pharmacokinetic/ statistical SOPs.

• Should be able to perform QA review (whenever required) in the bioanalytical and pharmacokinetic/ statistical sections of the study protocols.

• Should be able to assist or conduct periodic internal quality system or facility audits in different processes, instrumentation and software applications and its documentation in bioanalytical and pharmacokinetic/ statistical departments.

• Should be able to assist or conduct whenever required audits of quality system or facility, as part of regulatory inspection/sponsor audit readiness program.

• Should be able to prepare and issue audit reports and follow-up the implementation of CAPA to ensure closeout of the audits observations. whenever required assist manager/HOD to collate quality systems data for trend analysis of QA metrics.

• Should be able to prepare QA statements for bioanalytical validation reports and final study (PK & Statistics part) reports as per the scheduled time lines.Should be able to assist or conduct onsite or desktop audit of vendors as per the vendor assessment/reassessment schedule

• Should be able to perform QA review SOPs for bioanalytical process, instrumentation and pharmacokinetic/ statistical process to ensure the compliance with internal SOPs, Principles of GLP, GCLP, GCP, GDP and other applicable regulatory requirements.

• Should be able to efficiently and professionally provide the required deliverables as bioanalytical QA auditor for GCP quality function.

• Should be able to author SOPs for GCP quality assurance function or other relevant function s SOPs and conduct training of relevant SOPs to staff of Clinical development Business unit.

• Should be able to periodically update and maintain own training records/binder and whenever required develop training plan and material and train the trainee auditors, trainee QC.

• Should be able to be responsible for delivering discussions /presentations on topics relevant to GxPs to the research staff.

• Should be able to collaborate with Bioanalytical /PK/Statistical functions in lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.

• Should be able to update and consult manager/HOD when delivering the current job responsibility and escalate immediately any quality and noncompliance observations to Head of GCP Quality and Compliance.

• Should be able to perform or assist any other relevant job with relevant training as and when required by Head- GCP Quality and Compliance or Management.

• Should be able to periodically update the required technical, scientific, regulatory affairs knowledge with respect to the required national & international drug regulatory guidance and quality standards.

Keyskills :
bioanalytical calibration decoding sop qualityassurance current auditreports trendanalysis qualitysystem datamanagement qualitysystems methodvalidation tatementsofworksow