Computer System Validation

1 week ago

Kanpur, Uttar Pradesh, India People Prime Worldwide Full time

Our is Client is a largest Top 5 Software giant in India, with over 11.3 USD billion dollars revenue, Global work force 2,40,000 employees, It delivers end-to-end technology, consulting, and business process services to clients across the globe, Presence: 60+ countries and Publicly traded company NSE & BSE (India), NYSE (USA).

· Job Title:Computer System Validation Engineer

· Location: Bengaluru, hyderabad

· Experience: 5+ years

· Job Type : Full Time Permanent

· Notice Period:- Immediate joiners

. Client : MNC Client

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

Required Skills and Experience

  • Bachelor's degree (B.S.) in related field or equivalent.
  • 5-8 years 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.
  • 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 with enthusiasm.

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