Engineering Professional

6 days ago

Davangere, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Description:

Our organization is seeking a skilled professional to fill the role of Validation Engineer. In this position, you will be responsible for ensuring the quality and reliability of our products through validation and verification processes.

Requirements:

  • Bachelor's degree in a 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.
  • 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.

Preferred Skills and Experience:

  • Hands-on experience with Microsoft word, Excel, PowerPoint & Visio.
  • Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.

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