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GXP Test Lead

Katalyst Healthcares and Life Sciences

Job Description:

Summary
  • 15+ years of software QA/testing experience, with at least 10+ years in regulated environments like life sciences, pharma, healthcare.
Roles & responsibility
  • 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.
Education & Experience
  • Minimum requirement is a Bachelor's Degree in Computer Science, Sciences or a related education (e.g. life science, medicine), Masters preferable.
  • GxP, Validation Testing, QMS, Hand on in ALM/Codebeamer, Life Science Domain.
Vacancy posted 4 days ago
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