LIMS Specialist Job in Dublin
I am currently recruiting on behalf of a multinational pharmaceutical group for a LIMS Specialist 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:
* 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