Lead Validation Specialist
2 weeks ago
We are seeking a Highly Skilled Lead Validation Specialist to drive the validation processes of our cutting-edge products, ensuring they meet the highest quality standards.
Key Responsibilities
- Collaborate with Product, Engineering, and Testing teams to gain a comprehensive understanding of product functionalities.
- Review Product Requirements, including Epics, User Stories, and Software Requirements.
- Develop thorough test cases in Operational Qualification (OQ) and Performance Qualification (PQ) protocols, aligned with guidelines.
- Execute test cases, log defects, document deviations, and report test outcomes.
- Peer review test documentation to ensure quality and adherence to standards.
- Work collaboratively in a dynamic team environment with open communication.
- Understand and adhere to Quality Management System (QMS) standards.
- Lead a team of engineers, providing guidance, overseeing workload, and conducting reviews.
- Manage product validation timelines and ensure quality deliverables.
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.
- Proficiency with testing tools and Microsoft Office suite.
- Self-motivated with a willingness to quickly learn new technologies and products.
- Excellent interpersonal, writing, communication, and troubleshooting skills.
- Able to mentor colleagues and lead small projects efficiently.
About Us
We are ValGenesis, the market leader in end-to-end digital validation. Our cutting-edge products and expert team help life sciences companies improve quality and compliance.
Our Culture
- We prioritize customer success and keep the customer experience at the forefront of our decisions.
- We work together, communicate openly, and support each other to achieve our goals.
- We innovate and push boundaries to stay ahead of the market.
- We strive to be the number one intelligent validation platform in the industry.
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