Validation Lead

Skills / Experience

8+ years of experience in functional testing and Computer System Validation (CSV) in Life Sciences / Pharmaceutical domain

4 6 years of experience in GxP compliance, 21 CFR Part 11 and CSA guidelines

6+ years of experience with Waterfall, Iterative, and Agile methodologies

4+ years of proficiency with HP ALM (Application Lifecycle Management)

Job Description of Role

Testing & Validation Expertise : Extensive hands-on experience in testing and validation for medium to large system implementations

Methodologies : Skilled in Waterfall, Iterative, and Agile development methodologies

GxP Compliance : Strong knowledge of GxP compliance standards, including 21 CFR Part 11 and CSA guidelines

Computer Systems Validation (CSV) : Solid understanding of computer systems validation and related compliance practices

Experienced with SaaS and Cloud systems in GxP-regulated environments

Project Management : Proven ability to manage multiple concurrent projects with strong organizational and planning capabilities

Should have managed teams with a minimum size of 3 members

Prior experience in working on Agile / Scrum projects with exposure to tools like Jira / Azure DevOps

Experience in HP Application Lifecycle Management (HP ALM); Microsoft Office Suite (Project, Visio, Excel, PowerPoint)

Provides regular updates, proactive and due diligent to carry out responsibilities

Strong interpersonal skills to build and maintain productive relationships with team members

Provide constructive feedback during code reviews and be open to receiving feedback on your own code

Problem-Solving and Analytical Thinking; Capability to troubleshoot and resolve issues efficiently

Communicate effectively with internal and customer stakeholders (technical and non-technical )

Communication approach : verbal, emails and instant messages

Expected Outcome Leverage over 6 years of testing and validation expertise to ensure the successful delivery of compliant, high-quality system implementations within regulated environments. By applying proven methodologies (Waterfall, Iterative, Agile), strong project management capabilities, and a deep understanding of GxP compliance (including 21 CFR Part 11 and CSA), consistently drive projects to meet business, technical, and regulatory goals. Ensure risk mitigation and audit readiness through effective validation strategies, while enhancing team collaboration and stakeholder communication to deliver efficient, scalable, and compliant solutions in Life Sciences or pharmaceutical domains.