Job for M.Pharm, B.Pharm as Bioanalytical Auditor at Syngene International
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. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Post : Bioanalytical Auditor -GCP QA 1
• 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.
• 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: 5-6 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.
Qualification : M.Pharm, M.Sc
Location : India
Experience : 5-6 Years
Industry Type : Pharma
End Date : 10th June, 2019
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