Syngene Quality Assurance Job For Biotechnology & Microbiology
Syngene Quality Assurance Job For Biotechnology & Microbiology. Syngene MSc Biotechnology & Microbiology Executive – Quality Assurance – GLP Job. Check the details on the positions available, the job description, the key responsibilities, work experience, functional experience all below:
Designation: Executive – Quality Assurance – GLP
Job ID: 15944
Job Location: Bangalore
Department: Quality Assurance – GLP
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 also ICH GCP.
- Receipt and review of general documents/SOPs, MOA, Study Plans as well as Study Reports.
- Preparation and also/ or review of SOPs and also other documents connected to QAU.
- Maintain copies of approved Study Plans, MOA and general documents.
- Review of Method of Analysis and Study plan.
- Performing/scheduling study, facility as well as process-based inspections.
- Perform audit of study raw data & study report.
- Report the observations/findings of inspections to the respective auditee as well as 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 as well as GAMP.
- Follow environment, health, as well as safety (EHS) requirements at all times in the workplace guaranteeing individual as well as lab/plant safety.
- Attend training on environment, health, and safety (EHS) measures imparted company.
Educational Qualification: Master of Science in Microbiology/ Biotechnology
- Ought to be well versed with OECD GLP Principles, Bioanalytical Method development and also 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: 1-3 Years’ Experience.
- Strong commitment towards work, and also a high level of dedication, enthusiasm, motivation, and persuasive capability in a team.
- Good speaking-listening-writing skills, attention to details, proactive self-starter.
- Ability to work successfully in a dynamic, ambiguous environment.
- Capability to meet tight deadlines as well as prioritize workloads.
- Ability to develop new ideas and creative solutions.
- Should able to work in a team and also flexible for working in shifts.
- Need to be a focused employee.
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