GxP Test Lead

Primary & Secondary Skill : GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain

• 15+ years of software QA/testing experience, with at least 10+ years in regulated environments like life sciences, pharma, healthcare.
• Strong expertise in GxP compliance , CSV , and FDA 21 CFR Part 11 standards.
• Strong leadership, test planning, estimation, and cross-functional communication skills.
• Experience in testing SAAS/COTS/Bespoke , CRM , Life sciences systems , or lab systems (e.g., StarLIMS , Salesforce Health Cloud ).
• Hands-on proficiency in functional testing , test automation and performance testing tools (e.g., Tosca , NeoLoad ).
• In-depth understanding of Software Testing Life Cycle (STLC) process, QA tools and test management systems (e.g., JIRA , Client ALM , codebeamer ).
• Proficient in Agile , Waterfall , or hybrid Software Development Life Cycle (SDLC) methodologies.
• Experience integrating automated testing into CI/CD pipelines (e.g., Jenkins , GitLab CI ).
• Knowledge of data privacy/security standards (e.g., HIPAA ) relevant to software testing.
• Experience with risk-based testing approaches in regulated environments.
• Experience in System Migration and Mobile Testing

Qualification:

Minimum requirement is a Bachelor's Degree in Computer Science, Sciences or a related education (e.g. life science, medicine) , Master's preferable