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Computer Systems Validation Specialist

2 weeks ago

Ajmer, Rajasthan, India beBeeValidation Full time ₹ 20,00,000 - ₹ 40,00,000
Job Description

We are seeking a seasoned professional to spearhead computer system validation strategies and ensure regulatory compliance across our operations.

As a key member of our team, you will be responsible for developing and executing comprehensive validation plans, collaborating with cross-functional teams, and providing technical expertise to colleagues and clients.

">Required Skills and Qualifications
  • ">
  • A minimum of 5-8 years of hands-on experience in computer system validation/quality compliance within FDA-regulated industries (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
  • Strong knowledge of fundamental cGMP concepts, including FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 standards.
  • Hands-on experience in EDMS & Test Management tools, with the ability to develop clear, concise, and timely oral and written reports.
  • Excellent written and oral communication skills, with the ability to work on complex projects with general direction and minimal guidance.
  • Ability to handle multiple projects, meet deadlines, and manage priorities and workflow effectively.
">Key Responsibilities
  1. ">
  2. Develop and execute comprehensive Computer System Validation (CSV) strategies.
  3. Validate software applications and medical devices for regulatory compliance.
  4. Ensure adherence to FDA and international regulations, including GxP and 21 CFR guidelines.
  5. Collaborate with cross-functional teams to integrate validation activities into overall project plans.
  6. Provide technical expertise and support to colleagues and clients as needed.