Analytical Systems & Data Integrity Specialist

Analytical Systems, Data Integrity & Compliance
• 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.

• Perform and coordinate pre -inspection activities, including data integrity and
record reviews, user access and privilege reviews, process and documentation
checks.