QA Executive at Syngene – Biotech, Biochem & Microbiology – Apply Now !

“Hiring Alert: QA Executive at Syngene – Biotech, Biochem & Microbiology – Apply Now for Exciting Opportunities!”

QA Executive at Syngene – Biotech, Biochem & Microbiology Apply


Senior Executive – QA

Requisition ID: 55475


Department: Quality Assurance – GLP

Job Purpose


To 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 on handling the application software


3 to 6 Years

Behavioural Skills

  • 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 flexible for working in shifts
  • Should be a focused employee.

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