Crest Solutions have an opportunity for a Quality Business System Analyst to join our team and work on our customer site. The Quality Business Systems Analyst role provides support for Laboratory and Quality IT systems and identifies and implement continuous improvements, regulatory requirements, best practices, and efficiencies. The role is required to provide ongoing support and maintenance of Quality IT systems.

Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.

Responsibilities & Tasks

• Ensure that Quality IT systems are introduced, maintained / administered and used in a GxP compliant manner.
• Mapping of current and future state processes and to identify and implement continuous improvements, regulatory requirements, best practices, and efficiencies in a GxP manner. 
• User Access Management of Quality IT Systems.
• Master Data and Change Management of Quality IT Systems.
• Version Release Management of Quality IT Systems.
• Interface management for systems within scope of role.
• Technical / End User support for the site.
• Generation and update of system related documentation e.g. Change Control, URS, Functional Specification, IQ, OQ, UAT, PQ, SOP’s etc) and project execution to the required schedules as per the Site Digital/IT Roadmap.
• Ensuring that systems and implemented and configured to position the site to take advantage of Digital and paperless opportunities.
• Maintenance of key reporting tools and metrics.
• Work with relevant cross-functional project teams and stakeholders on monitoring, reporting and analysis of key KPI’s.
• Ensure that systems in his or her area meets Sanofi corporate and manufacturing/laboratory site standards.
• Execute system deployment / upgrade projects as per site ITS Roadmap.
• Ensuring that Data Integrity and GxP compliance is maintained within the Quality IT Systems at all times.

• 3rd level degree qualification in Science or IT, or equivalent significant years of experience in a similar role.
• At least 3 years’ experience in a similar role in a GxP environment.
• High level of technical knowledge and ability.
• Background in advanced use of Laboratory/Quality IT systems and computerised laboratory instruments in a GxP setting e.g. in Key User, Administrator, SME roles.
• Experience of the use, master data build, configuration and/or administration of Laboratory/ Quality IT systems e.g. LIMS (SampleManager or LabWare), Empower, NuGenesis SDMS and ELN, Documentum D2, QMS, laboratory standalone computerised instruments.
• Data Analytical skills e.g. proficient at using Excel, QlikView/QlikSense and advanced digital/ data analytics tools to analyse and present system related data.
• Experience of computer systems validation. 
• Good working knowledge of Laboratory GxP processes.
• Working technical knowledge of project execution and project management tools.
• Understands KPI’s for the team and site.