Bioanalytical QA Auditor

Job Description

• Responsible to perform project specific bioanalytical, pharmacokinetic (PK), statistical processes and data audits as per the QA SOPs and audit programs to ensure compliance with in-house bioanalytical, pharmacokinetic / statistical SOPs and applicable regulatory guidance s as GCP QA bioanalytical auditor as per the scheduled timelines for Clinical Development Business unit.
• Responsible to perform audits and review of processes, 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 in-house bioanalytical SOPs.
• Responsible to perform audits and review of processes, raw data and documents including SOPs of pharmacokinetic/statistical data management, analysis & reports to ensure the compliance as per the applicable regulatory guidance and in-house pharmacokinetic/ statistical SOPs.
• Responsible to perform QA review (whenever required) in the bioanalytical and pharmacokinetic/ statistical sections of the study protocols.
• Responsible 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.
• Responsible to assist or conduct whenever required audits of quality system or facility, as part of regulatory inspection/sponsor audit readiness program.
• Responsible 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.
• Responsible to prepare QA statements for bioanalytical validation reports and final study (PK & Statistics part) reports as per the scheduled time lines.
• Responsible to assist or conduct onsite or desktop audit of vendors as per the vendor assessment/reassessment schedule.
• Responsible to perform QA review SOPs for bioanalytical process, instrumentation and pharmacokinetic/ statistical process to ensure the compliance with internal SOPs, Applicable principles of GLP, GCLP, GCP, GDP and other applicable regulatory requirements.
• Responsible to efficiently and professionally provide the required deliverables as bioanalytical QA auditor for GCP quality function.
• Responsible 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.
• Responsible to periodically update and maintain own training records/binder and whenever required develop training plan and material and train the trainee auditors, trainee QC.
• Responsible to be responsible for delivering discussions /presentations on topics relevant to GxPs to the research staff.
• Responsible 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.
• Responsible 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.
• Responsible to perform or assist any other relevant job with relevant training as and when required by Head- GCP Quality and Compliance or Management.
• Responsible to periodically update the required technical, scientific, regulatory affairs knowledge with respect to the required national & international drug regulatory guidance and quality standards.
• Follow environment, health, and safety (EHSS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHSS) measures imparted company.

Educational Qualification: Masters in Life Sciences / M. PharmTechnical/functional Skills:Should be familiar with

• Bioanalytical methods & method validation.
• Liquid chromatography mass spectrometry.Experience: 06 09 yearsBehavioral Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.

• Good speaking-listening-writing skills, attention to details, proactive self-starter
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

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Keyskills :
bioanalyticalcalibrationdecodingsopquality assurancecommitment towards workequal employment opportunitycontinuous improvement facilitationstatements of work sow