IT Quality Specialist

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