Analytical Systems & Data Integrity Specialist
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Job Summary
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
Bachelors or Masters 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.
Required Skills:
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 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. Requirements QUALIFICATIONS EXPERIENCE AND COMPETENCIES 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.
Required Education:
Bachelors or Masters degree in chemistry pharmacy life sciences or a related
