The role is required to lead and execute the rollout of the Company corporate version of Waters NuGenesis 8 SDMS and ELN modules which will replace a legacy site-specific Waters NuGenesis 7 SDMS and Vision Publisher system.
The role will also deploy other computerized system deployments/upgrades as required by Project Roadmaps. The Quality Business Systems Analyst role also provides support for Laboratory and Quality IT systems (Deviations Management System, Documentum D2 Documentation Management System, Empower 3, NuGenesis 8 SDMS/ELN Sample Manager LIMS, Digital Tools). Ensures that quality IT systems are introduced, maintained/administered, and used in a GxP compliant manner. Identifies and implements continuous improvements, regulatory requirements, best practices, and efficiencies.
• Experience of the use of Waters NuGenesis 8 SDMS and ELN, preferably as an SME / Key User / Administrator.
• Ability to configure templates within NuGenesis to allow file and print data capture to NuGenesis from standalone laboratory computerized systems.
• Experience in configuring ELN workflows and calculations using the NuGenesis 8 ELN module.
• Experienced at creating site procedures (SOP’s, Work Instructions, training courses/resources) and delivering training on the content.
• Experienced at writing and executing qualification documentation (IQ/OQ/PQ) and change controls relating to computerized system deployment/upgrade.
• Familiarity with GxP Laboratory testing operations.
• The Quality Business Systems Analyst role provides support for Laboratory and Quality IT systems (Deviations Management System, Documentum D2 Documentation Management System, Empower 3, NuGenesis 8 SDMS/ELN Sample Manager LIMS, Digital Tools).
• Ensures that Quality IT systems are introduced, maintained/administered and used in a GxP compliant manner.
• To map 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 the scope of the 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/ITS Roadmap.
• Ensuring that systems are implemented and configured to position the site to take advantage of Digital and paperless opportunities.
• Work with relevant cross-functional project teams and stakeholders on monitoring, reporting, and analysis of key KPIs.
• Ensure that systems in their area meet Company corporate and manufacturing/laboratory site standards.
Ensuring that Data Integrity and GxP compliance is maintained within the Quality IT Systems at all times.
• 3rd level degree qualification in Science, IT or Engineering, 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 in relation to GxP computerized systems.
• Background in the advanced use of Laboratory/Quality IT systems and computerized laboratory instruments in a GxP setting e.g. in Key User, Administrator, SME type roles.
• Experience of the use, master data build, configuration, and/or administration of Laboratory / Quality IT systems e.g. LIMS (SampleManager and/or LabWare), Empower, NuGenesis SDMS, and ELN, Documentum D2, QMS, laboratory standalone computerised instruments would be an advantage.
• Experience of computer systems validation (CSV) would be a distinct advantage.
• Good working knowledge of Laboratory GxP processes.
• Familiar with audit trail review / assessment on GxP computerised systems.
• Working technical knowledge of project execution and project management tools
Purpose: This is an 11 month maternity cover contract. The Medical lead is a non-promotional Head Office role and part...Apply For This Job
This is an 11- month contract. Purpose: The IT Workstream lead will drive the development and provision of all IT...Apply For This Job
This is an 11 month contract This would be for two cycle shift (Day Shift- Mon-Thur 07:00-15:00, Friday 07:00-14:00, Evening...Apply For This Job
Purpose This is an 11 month contract The OEM Area lead will drive the development and provision of all associated...Apply For This Job
Purpose: This is an 11 month contract. This is a contract based role for a QC Laboratory Technician, as part...Apply For This Job