Validation Engineer

2 weeks ago

Hyderabad, Telangana, India People Prime Worldwide Full time

About Client:

Our client is an Indian multinational technology company based in Bengaluru . It provides information technology , consulting and business process services, and is one of India's Big Six IT services companies. Services include cloud computing , computer security , digital transformation , artificial intelligence , robotics , data analytics , and other technologies.

  • Job Title : Validation Engineer
  • Job Locations : Bangalore/Hyderabad
  • Experience : 5-10 Yrs
  • Employment Type : Full time
  • Notice Period : Immediate joiner - 30Days (Notice period)

Mandatory Skills:

  • 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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