IT Quality Specialist

Job Summary

A company is looking for an IT Quality Specialist responsible for ensuring compliance and continuous improvement of computerized systems in the pharmaceutical environment.

Key Responsibilities

• Draft, execute, and manage computerized system periodic reviews in line with regulatory and company requirements
• Manage CAPAs and deviations, ensuring timely investigation and effective corrective/preventive actions
• Review and approve validation deliverables for compliance with GxP and data integrity requirements

Qualifications

• Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or related discipline (or equivalent experience)
• 3+ years of experience in IT Quality, Computer System Validation (CSV), or related Quality roles within the pharmaceutical or life sciences industry
• Strong understanding of GxP regulations (21 CFR Part 11, Annex 11, FDA, EMA, ICH guidelines)
• Hands-on experience with CAPA/deviation management systems and periodic review processes
• Excellent technical writing skills for SOPs, WIs, and job aids