About this role
The Analytical Systems & Data Integrity Specialist supports Analytical Development laboratories by coordinating and harmonising data integrity practices for analytical computerised systems across the department.
The role is hands-on, with strong involvement in day-to-day laboratory and system-related activities, and ownership of selected transversal activities, such as supporting review, alignment, and continuous improvement of practices and data integrity-related processes. The incumbent acts as both a specialist and a coordinator, working in close collaboration with scientists, Quality Assurance (QA), and IT.
MAJOR RESPONSIBILITIES
• Act as a specialist for analytical computerized systems (e.g. Empower,
Softmaxpro, standalone systems …).
• Support analytical scientists in the compliant and data-integrity-aligned use of
laboratory systems, in accordance with ALCOA+ principles.
• Provide support for questions related to data access, result review, audit trails,
and data traceability.
• Execute data integrity checks on analytical data and system records.
• Support system configuration reviews (user roles, access, privileges).
• Support system validation activities through document review and coordination
with QA and IT.
• Support deviation investigations, root cause analysis, and CAPAs related to
analytical data or systems when required.
Harmonization of Practices & Inspection Readiness
• Coordinate and support the harmonization of analytical development practices
(Result locking and sign-off processes, management of user privileges and
access rights, use and review of audit trails)
• Identify differences in practices across teams and propose simple, consistent,
and compliant ways of working.
• Support the creation or update of procedures and guidance documents related
to data integrity and analytical systems.
• Support inspection and audit readiness for Analytical Development laboratories.
record reviews, user access and privilege reviews, process and documentation
checks.
Requirements
QUALIFICATIONS, EXPERIENCE AND COMPETENCIES
• Bachelor’s or Master’s degree in chemistry, pharmacy, life sciences, or a related
scientific field.
• 5 years of relevant experience
• Solid experience working in GxP and Data Integrity environments.
• Hands-on experience with analytical laboratory systems (e.g. Empower,
SoftMax Pro…).
• Good understanding of data integrity principles and analytical data lifecycle.
• Hands-on, structured, and able to work independently.
• Able to coordinate and align ways of working across teams.
• Clear communication.
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