System Validation Specialist

2 days ago


Bhavnagar, Gujarat, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000

About us:

We are a global technology company providing innovative solutions in information technology, consulting, and business process services.

  • Mandatory Skills:
  • Familiarity with Computer System Validation/Quality Compliance in a regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
  • Understanding of fundamental regulatory concepts and FDA/EMA guidelines, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong knowledge of regulated manufacturing processes, process validation, computer and equipment validation, and Good Manufacturing Practices.
  • Familiarity with Electronic Document Management systems & Test Management tools.
  • Awareness of recent regulatory guidance on transitioning from CSV to CSA.
  • Excellent written and oral communication skills.
  • Ability to work on complex projects with general direction and minimal supervision.
  • Capacity to handle multiple projects and meet deadlines.

Main Responsibilities:

  • Develop clear, concise, and timely reports.
  • Manage priorities and workflow. Versatility, flexibility, and a willingness to work within changing priorities.


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