Kate Shields Email & Phone Number

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Waterford, Ireland

A member of the Quality Technical Analysis (QTA) team.I work as part of the Method Qualification, Validation and Transfer team. Currently working on validating test methods for products moving into Clinical Trials. My job involves writing and executing qualification and validation protocols, and compiling the study data generated into reports. I have worked on Validation of test methods for Identity by Dot Blotting, Concentration, Oxygen Headspace, Free Thiol, Kinetics and Enzyme Activity. I draft and update test method procedures, SOPs and control forms on site, generate memos and perform control qualifications.I also provide support for engineering, clinical trial and stability batch testing. l work closely with the Technical Development team on their studies.

Ringaskiddy

I worked within the Stability Unit at ISL, Novartis for two years.My responsibilities included:Carrying out testing of a wide variety of drug substances for release, stability and validation in accordance with valid testing procedures and regulatory requirements. Use of techniques such as TGA, Specific Optical Rotation, Loss on Drying, IR, DSC, Titration, HPLC and UV for the analysis of these substances.Writing necessary reports such as OOS/OOE, CAPA and deviations on Trackwise (AQWA) system.Updating SOP and AGD documents when deemed necessary.Inputting of results into raw data binders and into the SAP system.Liaising with other analysts to plan testing schedule using Vitro tool and LabPlan.Ensuring all target dates are met.Member of Quality Matters and Behaviour Based Quality teams.Supporting projects such as 5S and Lean labs.

Ireland

FMC BioPolymer harness nature's renewable resources to create ingredients and technical solutions for the food ingredients, pharmaceutical, and biomedical markets. During my placement I worked as a lab analyst in the Quality Control Laboratory which involved the testing of products such as; tablet binders, suspension aids and super disintegrants, in accordance to the valid testing procedures. I also ensured that all laboratory equipment was well maintained, that all calibrations were completed in a timely manner and that the laboratory was maintained to a high working standard.Other duties of my position were assisting in SOP reviews, compiling Word, Excel and Powerpoint documents for all of the testing carried out and covering day and night Shift patterns within the QC Laboratory.Additionally I covered day and weekend Shift within the Microbiology Laboratory. My duties within this Lab were to; test the packaging samples for pathogens like Staphylococcus, Pseudomonas, Salmonella, E.Coli, Total Plate Count and Total Coliform and also to test for Yeast and Mould. I was also taught how to test air filters from around the plant, perform air sample tests within packaging rooms and to test the air flow within the lab-hood of the micro lab.From this placement I gained familiarity with Good Manufacturing Practices (GMP), I developed my teamwork skills from working as part of the Quality Control team and I attained good levels of independent learning.