Systems Validation Specialist

1 week ago

Noida, Uttar Pradesh, India beBeeComputer Full time ₹ 8,00,000 - ₹ 12,00,000

Job Opportunity:

We are looking for a highly skilled and experienced professional to lead the validation and testing of computer systems. The ideal candidate will have in-depth knowledge of regulatory standards and be able to ensure that all documentation meets these requirements.

About the Role:

  • The successful candidate will be responsible for leading the validation and testing process, including authoring major deliverables and reviewing CSV documents.
  • They will also identify and prioritize system requirements, documented in a software requirements specification.
  • An additional key responsibility will be to communicate interdependencies across multiple teams and drive convergence to ensure smooth functioning.
  • Another critical aspect of this role will be managing stakeholder communications and responding to enquiries.
  • The candidate will also develop and maintain detailed validation and testing documentation, including validation plans, test cases, and reports.
  • Collaboration with Digital, business, and Quality Assurance teams will be essential to understand system requirements and ensure appropriate coverage in testing documentation.
  • A strong understanding of regulatory standards and internal policies will be crucial in ensuring compliance.
  • Additionally, the candidate will participate in validation and testing activities, providing support in the execution of test cases and recording results.

Requirements:

  • A bachelor's degree in Life Sciences, Information Technology, Engineering, or a related field is required.
  • The ideal candidate will have at least 5 years of relevant job experience in a regulated (GxP) environment.
  • Experience with Regulatory standards and deliverables is a must.
  • Hands-on experience with Spotfire, Statistica, and Redshift is desirable.
  • A proven track record in Computer System Validation with a strong understanding of CSV/SDLC practices is essential.
  • Excellent problem-solving, communication, and documentation skills are required.

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