Dublin, County Dublin, Ireland
I am a lab tech consultant with 3 years of experience in Pharma's IT and Science sectors, covering IT, EQV, CSV, and QA. The QC & MSAT labs I have serviced to this day use the equipment I qualified and maintained with analysts and vendors. My Quality background is built on Veeva Vault through authoring key SOPs, WIs, and KBAs, and owning difficult Deviations, CAPAs, and Change Controls. I have installed and validated software systems for AV, DR, 21CFR p11, all in compliance with GxP, ISO, and GAMP. Many of my best achievements are process optimisations in SNOW, Power Automate, and Smartsheet, addressing budget/resource constraints.
• Authoring, reviewing and managing technical risk assessments • Maintaining the manufacturing process's documentation • Sourcing and evaluating data to look for process improvements • Supporting other departments on technical issues • Providing expertise on their area of speciality • Raising, overlooking and resolving deviations and supplier change notifications (SCNAs) Most notable duties and achievements accomplished as part of the job: • Re-formatting, editing and uploading employees' process-improvement projects onto an online system. • Reconciliation of materials' quantities in Bill of Materials • Updating Process Description documents • Making an interactive Gantt chart on excel to facilitate the team's understanding of which phase of the manufacturing campaign the plant is in • Assessing and confirming solubility values of buffers and media to be used in the manufacturing of a new drug • Reviewing ALXN-QD-0013265, Cleaning Downstream Sample Plan for Alexion Dublin Bulk Drug Substance. • Visualising yield data to be presented to leads • Updating Single Use Filtration Assemblies PCM Report ALXN-QD-0011576 in approval • Compiling MBR scans for the Korean audit visiting the site • Technical assessment for not procuring TOC swabbing as part of Cleaning Validation for shakedown campaigns • Technical assessment for not procuring TOC rinse and swab sampling as part of Cleaning Validation for post-column packing. • Periodic review of PCM report • TRA update regarding extension of shelf life of a material • Bill of Materials update to include new NOF PS80 • Compiling an interim cleaning validation pack for chrom skids • Writing a report related to the pack • SCNA handling • SCNA job aid, establishing a one-for-all procedure for the handling of SCNAs
• Provide high level of customer service. • Process cash and credit card payments. • Stock products on the shelves.
• Aquarium cleaning and maintenance. • Preparing food for sharks and animals. • Responding to client queries and allocating to a different team member if required. • Responsible for workplace sanitation.