QA Executive at Syngene – Biotech, Biochem & Microbiology Apply
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.
Senior Executive – QA
Requisition ID: 55475
Job Location: Bangalore
Department: Quality Assurance – GLP
Job Purpose
To ensure compliance with Organization for Economic Co-operation and Development (OECD) principles of Good Laboratory Practices (GLP), Good Clinical Laboratory Practices (GCLP), and ICH GCP.
Key Responsibilities
- Receipt and review of general documents/SOPs, MOA, Study Plans, and Study Reports
- Preparation and /or review of SOPs and other documents related to QAU
- Maintain copies of approved Study Plans, MOA, and general documents
- Review of Method of Analysis and Study plan
- Performing/scheduling study, facility, and process based inspections
- Perform audit of study raw data & study report
- Report the observations/findings of inspections to the respective auditee and management in a timely manner
- Review of electronic data and audit trail for data generated in bioanalysis
- Review of computerized system documents with respect to OECD 17, 21 CFR Part 11, and GAMP
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
- Attend training on environment, health, and safety (EHS) measures imparted compa
Educational Qualification
Masters Degree M. Pharm / Masters of Science (Microbiology / Biotechnology/Biochemistry)
Technical/Functional Skills
- Knowledge in OECD GLP Principles, Bioanalytical Method development and Validation Guidance (Such as USFDA, EMEA, ANVISA), GCLP Guidance, ICH- GCP Guidance
- Well versed in electronic data audit
- Good Knowledge on handling the application software
Experience
3 to 6 Years
Behavioural 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
- Ability to lead a small team
- Should be able to work in a team and flexible for working in shifts
- Should be a focused employee.
Keywords: QA Executive Jobs, Syngene, Biotech, Biochem, Microbiology, Quality Assurance, GLP, Bangalore. QA Executive at Syngene – Biotech, Biochem & Microbiology Apply. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
