Electronic Data Integrity QA Specialist

vor 2 Wochen

Bulle, Schweiz Randstad Vollzeit

Jobdescription Location: Bulle, Switzerland Activity rate : 100% Type of contract: Temporary contract Start date: End date: (potential extensions) We are looking for an experienced Electronic Data Integrity QA Specialist to join the Quality Assurance team of UCB.In this role, you will act as a QA subject matter expert in data integrity, computerized system validation (CSV), and automation within a biotech manufacturing environment. You will review and approve qualification and validation deliverables, oversee change management, and ensure full compliance with GxP, data integrity, and UCB procedures.You will collaborate closely with QA, engineering, IT, and operations to ensure data integrity and system reliability across automated platforms such as MES (Syncade) and DCS (DeltaV). Your key responsibilities: Review and approve change controls, deviations, and CAPAs related to computerized systems and automation. Review and approve qualification and CSV documentation (URS, FRA, Qualification Reports, etc.). Evaluate change impacts and define risk-based qualification strategies ensuring data integrity and regulatory compliance. Provide QA oversight for MES (Syncade), DCS (DeltaV), and Windows-based software upgrades. Approve equipment qualification reports in line with GMP and company procedures. Ensure QA compliance with electronic data integrity (e-DI) standards and GxP requirements. Identify and monitor critical data assets within manufacturing and QC environments. Perform QA reviews for automation and validation deliverables, ensuring technical consistency and traceability. Support and improve data integrity processes (audit trail reviews, risk assessments, etc.). Participate in quality strategies and project reviews to embed data integrity principles. Coordinate with internal/external stakeholders (QA, Engineering, IT, CMOs) to ensure quality alignment. Map and analyze data flows to reinforce control and oversight of critical systems. Support strategic projects through QA review of qualification and CSV documentation. Act as a data integrity and CSV expert, providing QA guidance and promoting continuous improvement. Qualifikationen What will make you successful: Bachelor's or Master's degree in Life Sciences, Engineering, or a related field. QA professional with at least 5 years of experience in the biotech or pharmaceutical industry, ideally within a GMP-regulated environment. Proven expertise in CSV and automation systems, including MES (Syncade) and DCS (DeltaV) qualification and recipe validation. Strong knowledge of data integrity principles, change control, deviations, investigations, and CAPA management. Solid understanding of computerized system qualification and related deliverables (URS, FRA, qualification reports, etc.). Skilled in project planning and prioritization, able to manage multiple QA activities efficiently. Excellent communication and negotiation skills, with the ability to influence and collaborate across QA, engineering, and operations teams. Fluent in French and English (oral and written).

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