The Validation Lead is responsible for driving end-to-end validation activities across systems, processes, or applications, ensuring compliance with regulatory and quality standards. This role involves defining validation strategies, overseeing execution, coordinating with cross-functional teams (including vendors, development, quality, and business), and ensuring accurate documentation and traceability.
- Lead validation planning activities, including defining overall validation strategy, approach, and timelines.
- Develop, review, and approve validation deliverables such as validation plans, strategies, and reports.
- Review key project documents such as User Requirements Specifications (URS), Functional Specifications (FS), Design Documents, and Risk Assessments.
- Utilize and manage test plans in HP ALM QC
- Coordinate with development teams and quality teams to develop Operational Qualification (OQ) scripts.
- Collaborate with business stakeholders to develop Performance Qualification (PQ) scripts.
- Conduct dry runs of OQ and PQ scripts during the development phase to ensure readiness and eliminate errors.
- Oversee execution of validation protocols ensuring compliance and completeness.
- Proven experience in validation within regulated industries (pharmaceutical, biotechnology, or healthcare).
- Hands-on experience in Computer System Validation (CSV) or similar validation frameworks.
- Experience working with HP ALM QC (mandatory),
- Strong knowledge of validation lifecycle (URS ? FS ? Design ? IQ/OQ/PQ ? Reporting).
- Experience with OQ and PQ script development and execution.
- Familiarity with regulatory standards such as GxP, FDA 21 CFR Part 11, and EMA guidelines.
- Expertise in validation documentation, traceability, and audit readiness.
At Space, we're not just building software; we're crafting digital solutions that redefine industries. We believe in the power of technology to transform businesses and lives. Our culture is one of innovation, collaboration, and a relentless pursuit of excellence. We foster an environment where ideas are nurtured, and potential is maximized.
Joining Space means becoming part of a dynamic team that's at the forefront of technological advancements.You'll have the opportunity to work on challenging and rewarding projects, alongside some of the brightest minds in the industry. We offer a competitive compensation package, comprehensive benefits, and ample opportunities for professional growth.
But what truly sets us apart is our commitment to our employees. We believe in investing in our people, providing them with the tools, resources, and support they need to succeed. We encourage a healthy work-life balance and promote a positive and inclusive workplace culture. If you're passionate about technology and eager to make a meaningful impact, Space is the place for you.