A 12 month temporary assignment currently exists for a Senior Associate - QO IT Support to be part of the QC team in a supporting function with responsibility for administration of all Laboratory IT systems.

Responsibilities include, but are not limited to:

• System Administrator responsible for the computerized systems in Quality Operations. This will include:
• Control of system access forms
• Creating and de-activating user accounts
• Assigning user ID and application passwords
• Liaising with CIT to ensure effective timely disaster and backup recovery of all applications
• Periodic review of Audit trails
• Archival of data
• Administration and day to day support of Cerity/ Empower applications
• Delivery of Cerity/ Empower training to new QC Analysts
• LIMS support for QC
• Trainer for LIMS and Cerity
• Investigate and resolve LIMS method and report issues
• Build product templates in LIMS
• Management of QC VLAN network
• Execution of CFR 21 Part 11 OQ for all new computerized systems
• Generation of ERES (Electronic record Electronic Signature) assessments
• Retirement of Part 11 compliant systems
• Maintaining all QC computerised systems in a validated state
• Assisting with the preparation of Life Cycle documentation
• SME for Novatek EMS (Environmental Monitoring Software) solution
• SME for software applications related to Biologics assays including Biomek 3000, Spectramax microplate reader, UV spectrophotometer, CPassay, Densitometer, Capillary Electrophoresis and Bioanalyser
• Validation of spreadsheets for custom calculations
• Troubleshooting issues with software applications in conjunction with site IT department

Knowledge and Experience:

The successful candidate will:

• Hold a third level qualification in a Science discipline
• Applicable IT qualification would be advantageous
• Have relevant experience in a pharmaceutical laboratory
• Proven industrial experience with administration of Laboratory IT systems
• Be proficient in the use of Microsoft Office etc
• Good Report writing skills

· Key attributes: organised, self starter, proactive, responsible and flexible


For more information contact Jenny Navan on 01 614 6072 or Jenny.Navan(at)cpl.ie