IT Quality Specialist

Position Summary

The IT Quality Specialist is responsible for ensuring the compliance, integrity, and continuous improvement of computerized systems within the pharmaceutical environment. This role focuses on executing and maintaining IT Production Operations and Technology (PO&T) department deliverables, including periodic reviews, CAPA and deviation management, user access review, validation document review, and the development of standard operating procedures (SOPs), work instructions (WIs), and job aids. The IT Quality Specialist collaborates with cross-functional teams to maintain adherence to regulatory requirements (e.g., FDA, EMA, GxP) and internal quality standards.

Key Responsibilities

• Draft, execute, and manage computerized system periodic reviews in accordance with regulatory and company requirements.
• Manage CAPAs and deviations, ensuring timely investigation, root cause analysis, and effective corrective/preventive actions.
• Review and approve validation deliverables (e.g., URS, IQ/OQ/PQ, test scripts, summary reports) for compliance with GxP and data integrity requirements.
• Draft, revise, and maintain SOPs, Work Instructions, and job aids to ensure alignment with current regulatory expectations and internal processes.
• Partner with IT, Quality, and Business stakeholders to support audits, inspections, and continuous improvement initiatives.
• Monitor trends in IT quality events and provide input into risk assessments and process improvements.
• Ensure documentation practices are consistent with data integrity principles (ALCOA+).

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.
• Ability to work cross-functionally and communicate effectively with both technical and non-technical stakeholders.
• Strong analytical and problem-solving skills with attention to detail.

Preferred Qualifications

• Experience with electronic systems such as Veeva QualtiyDocs, TrackWise, or equivalent.
• Familiarity with audit/inspection management.
• Knowledge of pharmaceutical manufacturing and laboratory systems (e.g., LIMS, MES, ERP).

Contact:

Should you have any questions please contact our Head of Recruiting: [email protected]