Syngene Hiring! Biotech, Biochem & Microbiology With 6 Months Exp Apply Online


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Syngene Hiring! Biotech, Biochem & Microbiology With 6 Months Exp Apply Online

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Requisition ID: 55473

Job Location: Bangalore

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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.

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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

  • 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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