Syngene Hiring! Biotech, Biochem & Microbiology With 6 Months Exp Apply Online
Designation: Executive – QA
Requisition ID: 55473
Job Location: Bangalore
Department: Quality Assurance – GLP
About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to various industries worldwide. Syngene’s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. With a strong team of 4240 scientists, Syngene aims to solve scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.
Job Purpose
The Executive – QA will 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 of handling application software
Experience
0.6 to 3 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 be flexible for working in shifts
- Should be a focused employee
Apply Online: Click here
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