System Validation Specialist

2 days ago


Allahabad, Uttar Pradesh, India beBeeQuality Full time US$ 12,00,000 - US$ 15,00,000

About Our Company:

We are a global technology organization that provides IT, consulting, and business process services.

We specialize in cloud computing, computer security, digital transformation, artificial intelligence, robotics, data analytics, and other technologies to drive business growth.

Key Responsibilities:

  1. Lead the validation of computer systems to ensure compliance with FDA regulations and industry standards.
  2. Develop and implement quality assurance processes to maintain high-quality products and services.
  3. Analyze data to identify trends and areas for improvement in our systems and processes.
  4. Collaborate with cross-functional teams to resolve issues and achieve project goals.

Requirements:

  • 5-8 years of experience in computer system validation or quality compliance in FDA-regulated industries (Medical Device/Pharma/Life Sciences).
  • Fundamental knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.
  • Strong understanding of FDA-regulated manufacturing processes, process validation, computer and equipment validation, and GMPs.
  • Hands-on experience in electronic document management systems (EDMS) and test management tools.
  • Understanding of FDA's guidance on CSV to CSA transition.


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