Website Ref: TPM04563
A QC Systems Specialist is required for a biotech company in Carlow. The incumbent 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 successful candidate will act as LIMS Site Administrator, Empower administrator and SAP (QM) master data maintainer for the site Laboratories and is required to be a subject matter expert in these areas.
- Provide efficient support to all departments at our client’s site including QC Microbiology, Quality Control and Operations for issues pertaining to LIMS, Empower and SAP, and to be a subject matter expert for these systems.
- Deliver systems training to new hires and as additional roles are required for existing personnel.
- 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 on site.
- 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.
- Coach and guide colleagues onsite and in the network on the use of Laboratory Systems.
- Required to comply with our client’s Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
- Work collaboratively to drive a safe and compliant culture on site.
- May be required to perform other duties as assigned.
Qualifications & Experience:
- Bachelors Degree or higher preferred; ideally in Science/IT or a closely related discipline
- 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.
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