QC Systems Specialist
Hybrid role – Mainly remote, some onsite training required
The QC systems specialist role will provide in-line technical support in relation to Laboratory Systems such as LIMS, Empower, SAP and Lab X to ensure the continued manufacture and supply of quality pharmaceutical products. The role supports all internal customers including QC, QA, Automation and Operations
Provide efficient support to all departments including QC Microbiology, Quality Control and IPT for issues pertaining to LIMS, Empower and SAP, and to be a subject matter expert for these systems.
Development and testing of systems master data. Perform new master data builds for the introduction of new products in line with analytical change control requirements to ensure the functionality is available in line with site schedule requirements.
Provide technical support to all users. Liaise with Global systems working groups.
Provide subject matter expertise in relation to Laboratory Systems. Works on improvement projects in relation to LIMS and other laboratory systems as required.
Qualifications and Experience:
· Considerable experience and critical skills in the area of expertise that add value to the business; ideally in Laboratory Systems setting. Preferably LIMS, Empower and SAP.
· Knowledge of data integrity requirements required.
· Change Management Skills (CEM) with continuous improvements.
· Knowledge of cGMP and GDP preferred
· Proficiency in Microsoft Office and job related computer applications required
· Lean Six Sigma Methodology experience desired
· Bachelors Degree or higher preferred; ideally in Science/IT or a closely related discipline