Visionary Systems Validator

1 day ago

Jamnagar, Gujarat, India beBeeRegulatory Full time ₹ 1,80,00,000 - ₹ 2,40,00,000
System Validation Engineer Job Description

Our client is a leading software giant with a global workforce, delivering end-to-end technology and business process services across the globe.

· Location: Bengaluru, Hyderabad

· Experience: 5+ years

· Job Type : Full Time Permanent

· Notice Period:- Immediate joiners

. Mandatory Skill:Computer System Validation,EDMS,Medical Domain,

Required Skills and Qualifications

  • Bachelor's degree in a related field or equivalent qualification.
  • 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
  • Knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong knowledge of FDA regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
  • Understanding of FDA's recent guidance on transition of CSV to CSA.

Benefits and Opportunities

  • Ability to develop clear, concise, and timely oral and written reports. Excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal guidance.
  • Ability to handle multiple projects and meet deadlines.
  • Ability to manage priorities and workflow. Versatility, flexibility, and a willingness to work within constantly changing priorities.

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