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.
Post : Senior Executive - GLP Quality Assurance
Job Description
Job Purpose:
• To Ensure the compliance to 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 company.
• Prepare the data for quality meetings.
Candidate Profile
• M.Pharm / Master of Science in Microbiology / Biotechnology/Biochemistry
• Should be well versed with 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
• 1-3 Years’ Experience.
• 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.
Additional Information
Experience : 1-3 Year
Qualification : M.Pharm, M.Sc
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : GLP Quality Assurance
End Date : 30th October, 2021
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