Computer Systems Validator

20 hours ago

Vijayawada, Andhra Pradesh, India beBeeSystem Full time ₹ 1,90,57,500 - ₹ 2,43,09,000
About the Role

We are seeking a motivated and experienced professional to join our team as a Computer System Validation Engineer.

  • This is an exciting opportunity to work with us, ensuring that computer systems meet the required standards and regulations.

As a key member of the team, you will be responsible for developing clear, concise, and timely reports, working on complex projects with general direction and minimal guidance, handling multiple projects and meeting deadlines, managing priorities and workflow, and staying up-to-date with FDA regulations, including cGMP concepts and recent guidance on transition of CSV to CSA.

Key Responsibilities
  • Develop and deliver high-quality reports in a timely manner.
  • Work independently with minimal supervision on complex projects.
  • Manage multiple projects simultaneously while meeting deadlines.
  • Prioritize tasks and manage workflow effectively.
  • Stay current with FDA regulations and industry best practices.

We are looking for an individual with strong analytical and problem-solving skills who can work effectively in a fast-paced environment.

The ideal candidate will have a solid understanding of FDA regulated manufacturing processes, process validation, computer and equipment validation, and GMPs. A bachelor's degree in a related field or equivalent is required. Additionally, 5-8 years of hands-on experience in Computer System Validation/Quality Compliance in a FDA regulated industry (Medical Device/Pharma/Life Sciences) is essential.

Requirements
  • Bachelor's degree (B.S.) in a relevant field or equivalent.
  • Minimum 5 years of experience in Computer System Validation/Quality Compliance in a FDA regulated industry.
  • Strong knowledge of electronic document management systems and test management tools.

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