Chief Validation Officer

1 day ago

Gandhinagar, Gujarat, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Overview

Our client is a leading provider of information technology, consulting, and business process services. Based in Bengaluru, they offer a wide range of services including cloud computing, computer security, digital transformation, artificial intelligence, robotics, and data analytics.

  • 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

  • Proven experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP system.
  • Familiarity with 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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