System Validation Professional

3 days ago

Shimoga, Karnataka, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Computer System Validation Engineer Role

We are seeking a skilled Computer System Validation Engineer to undertake critical tasks in our organization.

  • Job Description:
    Develop and execute comprehensive validation strategies for computer systems, ensuring compliance with FDA regulations and industry standards.
  • Key Responsibilities:
    • Design and implement thorough validation plans for new and existing systems.
    • Conduct rigorous testing and evaluation of system performance.
    • Collaborate with cross-functional teams to resolve validation-related issues.
    • Document and maintain accurate records of validation activities.
  • Requirements:
    • 5+ years of experience in Computer System Validation/Quality Compliance in a FDA Regulated industry.
    • Strong understanding 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.
    • Knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Benefits:
    • Opportunity to work on complex projects with general direction and minimal guidance.
    • Chance to develop clear, concise, and timely oral and written reports.
    • Possibility to manage priorities and workflow effectively.

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