On-site GxP Informatics & CSV Specialist (LIMS/ELN)
Pharmaron Beijing Co. Ltd.
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Benefits offered by this job
Job summary
Pharmaron Beijing Co. Ltd. seeks a Computer System Validation/QC Informatics Specialist to support laboratory data systems within QC & Analytical. You will manage CSV lifecycle, qualify GxP systems, and collaborate with IT and QA to ensure data integrity and compliance.
The role focuses on LIMS/ELN/SDMS platforms, data workflows, and system upgrades. On-site in Coventry, RI, with visibility to audits and continuous improvement of pharmaceutical informatics in a global CRO/CDMO.
Qualifications
- MSc or BS in Chemistry or CS required; 5+ years GxP experience preferred.
- Experience in IT supporting role with data terminology and lab workflows.
- Direct experience with laboratory informatics (LIMS) systems.
Responsibilities
- Lead qualification activities as part of CSV lifecycle (IQ/OQ/PQ).
- Support GxP software upgrades, installations, and rollouts with IT and QA.
- Maintain data integrity and adherence to 21 CFR Part 11 and data integrity principles.
- Provide user training and liaise between IT and lab staff to prioritize needs.
- Assist audits and regulatory inspections as directed.
Skills
Education
Tools
Job description
Pharmaron Beijing Co. Ltd. seeks a Computer System Validation/QC Informatics Specialist to support laboratory data systems within QC & Analytical. You will manage CSV lifecycle, qualify GxP systems, and collaborate with IT and QA to ensure data integrity and compliance.
The role focuses on LIMS/ELN/SDMS platforms, data workflows, and system upgrades. On-site in Coventry, RI, with visibility to audits and continuous improvement of pharmaceutical informatics in a global CRO/CDMO.
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