System Validation Specialist

2 days ago


Thiruvananthapuram, Kerala, India beBeeValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: System Validation Specialist

Our organization seeks a seasoned system validation professional to join our team.

Key Responsibilities:

  • Validate computer systems to ensure compliance with FDA/EMA regulations, QSR, 21 CFR Part 820, and ISO 9001 Standards.
  • Develop comprehensive reports on system validation results.
  • Work on complex projects with minimal guidance and manage priorities effectively.

Required Skills and Qualifications:

  • Bachelor's degree in a related field or equivalent.
  • 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a regulated industry.
  • Strong knowledge of cGMP concepts and GMPs.
  • Hands-on experience in EDMS tools.
  • Understanding of recent regulatory guidelines.

Benefits:

  • Opportunity to work on high-profile projects.
  • Chance to develop expertise in system validation and quality compliance.


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