Lead Validation Specialist

3 weeks ago


Chennai, Tamil Nadu, India ValGenesis Full time

Lead Validation Specialist

At ValGenesis, we're revolutionizing the life sciences industry with our cutting-edge digital validation lifecycle management system. We're seeking a skilled Lead Validation Specialist to join our team in Chennai.

Responsibilities:

  • Collaborate with Product, Engineering, and Testing teams to drive validation processes and ensure high-quality standards.
  • Review Product Requirements, including Epics, User Stories, and Software Requirements.
  • Develop thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
  • Execute test cases, log defects, document deviations, and report test outcomes.
  • Peer review test documentation to ensure quality and adherence to standards.
  • Lead a team of engineers, providing guidance, overseeing workload, and conducting reviews.

Requirements:

  • Bachelor's or higher degree in Computer Science, Biology, Biomedical Engineering, or a related field.
  • At least 8 years of experience in Computer System Validation and Product Software Validation in a regulated environment.
  • Deep knowledge of the product development life cycle.
  • Understanding of GMP, FDA, and ISO regulations.

We're on a Mission:

We're committed to delivering innovative solutions that enhance and expand our portfolio beyond validation with an end-to-end digital transformation platform.

The Team You'll Join:

  • We prioritize our customers' success and keep the customer experience centered in our decisions.
  • We work together, communicate openly, and support each other without reservation.
  • We think big and drive innovation in product development as well as personal growth.


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