System Validation Specialist

13 hours ago


Surat, Gujarat, India beBeeValidationEngineer Full time ₹ 1,80,00,000 - ₹ 2,20,00,000
Job Overview

About our client:

Our client is a leading software giant in India, with a global workforce and presence across the globe.

· JobTitle: Validation Engineer

· Location: HYderabad/Bangalore

· Experience: 5 - 10 yrs

· NoticePeriod:- Immediate - 30 days

Mandatory Skills:

  • Bachelor's degree in related field or equivalent required.
  • 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.
  • Strong knowledge of fundamental cGMP concepts and FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • 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:

  • 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.

Requirements:

  • Bachelor's degree in related field or equivalent required.
  • 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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