Dublin, Dublin

Posted an hour ago

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Job Description

Primary duties and responsibilities of the position are as follows. Other duties may be assigned.
Build and maintain specifications in the ALEXIS LIMS system.
Build and maintain sessions in VelQuest Smartlab
Administration of laboratory software systems.
Maintain data integrity and ensure compliance with FDA, GLP, QSR and cGMP regulations, as well as with company SOP’s and specifications.
Draft, review, and approve validation and qualification documentation for analytical software.
Draft, review, and approve SOPs, forms, and associated documentation with analytical equipment.
Management of laboratory instruments and standards through Labware LIMS.
Perform routine review of documentation generated by the QC laboratory, such as auditing laboratory data and supporting documentation (instrumental printouts, COAs, chemist notebooks, cumulative stability tables, protocols, reports, laboratory investigations, analytical test methods etc.) generated to support equipment qualification and calibration for accuracy, completeness, and compliance to requirements.
Initiate and facilitate Change Management Requests.
Author documents that ensure cGMP compliance, such as analytical test methods, analytical test method development reports, method validation protocols and reports, method verifications protocols and reports, and instrumentation qualification documentation (URS/IQ/OQ/PQ).
Seek process innovation and continuous process improvement in laboratory area.
Complete and conform to all training requirements for job role, including company-required and job-specific training.

Skills & Technologies

Python R MATLAB LIMS (Labware, ALEXIS)VelQuest Smartlab FDA regulations GLP cGMP QSR Method validation (IQ/OQ/PQ)

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Salary Information

Salary: $65000-95000

🤖 This salary estimate is calculated by AI based on the job title, location, company, and market data. Use this as a guide for salary expectations or negotiations. The actual salary may vary based on your experience, qualifications, and company policies.

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