Lead Validation Specialist
3 weeks ago
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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