Vacancy for M.Pharm, M.Sc as Bioanalytical Auditor at Syngene International

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Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.

Post : Bioanalytical Auditor -GCP QA 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.

Candidate Profile
• Master Degree in Biochemistry/Biotechnogy/ Chemistry or M Pharm  QA /pharmaceutics/Pharmacutical analysis with at least 5-10 years related experience  as Bioanalytical Auditor  in GCP Quality Assurance and Clinical Quality Management Systems environment.
• Minimum experience required: 3-5 years in performing independently Bioanalytical / Pharmacokinetic/statistical audits and review in GCP environment.
• Through knowledge in Bioanallytical and PK/Statistical regulatory guidelines (ICH, USFDA, EMA, MHRA,) governing clinical development.
• Highly motivated, agile and organized individual who can function in a fast-paced, multi-tasking environment. Able to work independently and as part of a multi-disciplinary team
• Strategic thinking and goal oriented with demonstrated good judgment and decision-making experience in a matrix environment
• Excellent attention to detail, time management and investigative skills, able to manage multiple priorities with urgency and thoughtful planning
• Must have strong written and oral communication skills in English language.
• Experience working with MS Office (Excel, Word, PowerPoint)
• Ability to work with cross functional groups /teams and handle difficult people/situations under pressure.
• Ability to communicate clear and accurate audit observations based on regulatory requirements and best practice, which gains acceptance from auditees.
• Ability to work with the senior management level in QA and with other partnering departments of business units.
• Ability to deal with competing timelines.
• Ability to work independently and as part of a team.
• Ability to prioritize work and handle multiple assignments.

Additional Information
Experience : 3-5 years
Qualification : M.Pharm, M.Sc
Location : India
Industry Type : Pharma
End Date : 05th March, 2019


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