Syngene International Ltd is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation.
Post : Quality Assurance Personnel (40201)
Job Purpose
• To Ensure the compliance to Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), CFR Part 11.
Job Description :
• Receipt and review of general documents/SOPs 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 SOPs, Study plans.
• 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 computerized system documents with respect to OECD 17,21 CFR Part 11.
• 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
• Master of Science in Microbiology / Biotechnology/Biochemistry/ M.Pharm
• 1-3 Years’ Experience.
• Should be well versed with OECD GLP Principles
• Should be aware of conducting inspections and audits
• 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 Years
Qualification : M.Sc, M.Pharm
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance GLP
End Date : 25th January, 2022
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