Ireland
ONLY INTERESTING IN SLIGO BASED OPPORTUNITIES. AREAS OF INTEREST: - LIMS, LES, ELN Implementation/Administration - Computer Systems Validation - Laboratory Systems Validation - QA IT
• Laboratory Systems Qualification - Biotek Endotoxin, TOC, SoloVPE, MALDI TOF, Osmometer, Densitometer • Installation and Configuration of Mettler Toledo LabX • SampleManager LIMS Implementation and Configuration • Active Directory Local Group and NTFS security permission configuration • ERES Assessments • Data Security Assessment • Data Integrity Assessments • Periodic Review - Remediation Plan execution • Liaise with vendors, service providers, local and global colleagues.
• Assessment of computer applications and manufacturing systems against GAMP 5, 21 CFR Part 11 regulatory requirements. • Generation, Execution, Review, and Approval of validation protocols and reports e.g. Software Validation Plan, Compliance Assessment, URS, ERES Assessment, IQ/QO/PQ. • Software Risk Assessment – Investigate legacy systems to determine compliance with current regulatory requirements as per FDA 21 CFR Part 11. • CAPA investigation and related activities.
• Consulted on the deployment of BIOVIA SmartLab LES (Laboratory Execution System) and CIMS (Inventory and Equipment Management Application). The ultimate aim was to create a completely paper free laboratory. • Infrastructural assessment of the Global Biologics Laboratory to identify the best solution for analyst interaction with new laboratory applications being deployed e.g. tablet, laptops or mobile workstations. • Developing a training program for LES and CIMS. The training will facilitate a seamless transition from a paper based laboratory to systems based environment.
• Successfully implemented Thermo LIMS, BIOVIA SmartLab LES and CIMS on time and under budget. • LIMS Master Data configuration – Build LIMS templates e.g. Test Methods, Specifications, Test Allocation, Sample Plans. • Configured Thermo LIMS to interface directly with SAP ERP and LES. • Performed UAT tasks on Thermo LIMS. • SmartLab LES – Coded new procedures via a BIOVIA proprietary scripting language. Created Parsing Techniques, which automated the transcription of data in PDF reports directly into BIOVIA LES. Configured RS-232 devices (pH Meter, Balances) and networked instruments (HPLC) to facilitate connection to LES via the network. • Performed the qualification of new instruments added to the network. • Globally certified trainer for SmartLab LES and Thermo LIMS. • Daily SmartLab and CIMS troubleshooting, liaising with Global support if necessary.