Job title: Bioanalytical QA Auditor
Job description: Designation: Executive
Job Location: Bangalore
Department: Quality Assurance-GCP
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.
- 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. Pharm
Should be familiar with
- Bioanalytical methods & method validation.
- Liquid chromatography mass spectrometry.
Experience: 0 3 years
- 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.
Equal Opportunity Employer:
It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Location: Bangalore, Karnataka
Job date: Tue, 04 Jan 2022 08:29:04 GMT
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