Syngene Quality Assurance Job
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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

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Job ID: 15944

Job Location: Bangalore

Department: Quality Assurance – GLP

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 also ICH GCP.

Job Description:

Key Responsibilities:

  • 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.
See Also
Merck Life Science CMC Regulatory Specialist Job - Apply Online

Educational Qualification: Master of Science in Microbiology/ Biotechnology

Technical/Functional Skills:

  • 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.

Behavioural Skills:

  • 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.

Apply Online

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