PSC Biotech Corporation

SAP Computer System Validation Analyst

PSC Biotech Corporation

full-time

Posted on:

Location Type: Remote

Location: California • United States

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About the role

  • Review pre‑executed SAP GxP test scripts for completeness, clarity, and alignment to requirements.
  • Review post‑executed test scripts for accuracy, proper evidence, deviations, and approvals.
  • Support test deviation management process.
  • Ensure documentation complies with FDA 21 CFR Part 11, Annex 11, GAMP 5, ALCOA+, and client validation procedures.
  • Collaborate with US QA, IT, and business teams on validation cycles and audit readiness.

Requirements

  • 3+ years of SAP CSV or SAP QA experience in a GxP regulated (pharma preferred) environment.
  • Strong knowledge of FDA regulations, CSV and CSA best practices.
  • Experience with SAP modules (SD/MM/PP/QM/WM/EWM) and test management tools (HP ALM, SolMan, Jira).
  • Excellent attention to detail and documentation quality.
Benefits
  • Permanent contract of employment
  • Learning & Development in-house training
  • Mentorship through constant guidance
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SAP GxPCSVQAFDA regulationstest management toolsHP ALMSolManJiraGAMP 5ALCOA+
Soft Skills
attention to detaildocumentation qualitycollaboration