CSA and CSV practitioner with Empower or HPLC software

Infinite Computer Solutions; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Infinite Computer Solutions is seeking a CSA and CSV practitioner with Empower or HPLC software to validate GxP-regulated IT systems in the Pharma/Life Sciences space. This remote role requires deep expertise in CSA, GxP data integrity, and QMS processes.

Candidates should be proficient in writing validation deliverables and risk-based testing strategies, with familiarity of 21 CFR Part 11 and Annex 11. Remote work setup is offered.

Qualifications

• Deep expertise in validating GxP-regulated IT systems in Pharma/Life Sciences.
• Familiarity with deviation management, CAPA, and change control within QMS.
• Strong command of CSA (Computer Software Assurance) principles.
• Solid knowledge of 21 CFR Part 11, Annex 11, ISPE AI guidance, and data integrity (ALCOA+).
• Ability to write and manage validation deliverables including test strategy (risk-based testing, CSA).

Skills

GxP IT validation

CSA principles

QMS deviation & CAPA

21 CFR Part 11

GxP data integrity (ALCOA+)

Job description

Title: CSA and CSV practitioner with Empower or HPLC software

Location: Remote

Skills & Experience Required:

• Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain
• Familiarity with QMS processes including deviation management, CAPA, and change control.
• Strong command of CSA (Computer Software Assurance) principles
• Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+).
• Proven ability to write and manage validation deliverables including Test Strategy (Risk-based testing, CSA),\ HPLC software