CSA/CSV Validation Specialist – HPLC Software

Location: Remote

Duration: Long-Term Contract

Required Skills & Experience: Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain. Hands-on experience with Empower HPLC software or similar chromatography data systems. Strong understanding of Computer Software Assurance (CSA) principles and risk-based testing. Knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, ISPE guidance, and GxP data integrity principles (ALCOA+).Experience with Quality Management System (QMS) processes, including deviations, CAPA, and change control. Ability to prepare and manage validation deliverables, including test strategies, risk assessments, test scripts, and validation documentation. Interested candidates: Please share your updated resume along with your current location, work authorization, availability, and expected hourly rate.📩 Please feel free to reach out or refer suitable candidates. Thanks & Regards, Sapna Daniel – Lead – US IT Recruitment✉️ sapna@quebecsol.com🔗 LinkedIn: sapna-daniel1a8512140🌐 Delivering Talent and driving Success. Connecting Top Talent with the Right Opportunities