Siobhan Dillon

Experience

• 

  Luker’s Bar & Restaurant

  Jan 2015 - Dec 2020

  Supervisor Role/ Bartender & Waitress

  In my previous role in the restaurant industry, I developed a strong foundation in customer service and honed my ability to thrive in a fast-paced, dynamic environment. Working directly with customers has enhanced my communication and interpersonal skills, ensuring that I can effectively convey complex information and collaborate with diverse stakeholders.The restaurant setting demanded adaptability, and I became adept at managing competing priorities, staying organized, and making quick decisions under pressure. For instance, during peak hours, I had to navigate a high volume of orders, ensuring accuracy and quality in every dish served. This experience not only sharpened my attention to detail but also cultivated my problem-solving skills as I addressed unexpected challenges to ensure a seamless dining experience for customers.One of the key strengths I bring from my restaurant background is a strong sense of teamwork. Collaborating with fellow staff members was essential to maintaining operational efficiency and delivering excellent service. I understand the importance of effective communication and coordination in achieving common goals. Show less

• 

  University of Galway

  Sept 2018 - May 2022

  Laboratory Analyst

  • Performed tests & analysis using appropriate technical equipment & instruments e.g. pH meters,centrifuges, Spectrophotometers, & sterilising equipment.• Complied with all safety, health & environmental rules & regulations & adhering to standard operating procedures with knowledge of GMP, GLP, quality systems & regulatory guidelines.• Undertook test methods to produce reliable data to support investigations using strict methodologies.• Recorded all results, logging the procedures & deviations that led to each experiment’s conclusion.• Prepared lab specimens like E. coli cultures & growth media showing Good Laboratory Practice.• Carried out techniques like SDS-PAGE, (RT-)PCR, Spectrophotometry, restriction enzyme digestion,cell-based assays, DNA ligation, metagenomic library creation, cell, protein/plasmid purification,Chromatography, western blot & agarose gel electrophoresis.• Utilised computers & IT to perform bioinformatical & statistical analyses (via SPSS).Demonstrated the use of various practical equipment & experimental techniques.• Oversaw the students carrying out experiments ensuring that they received assistance when necessary answering any queries regarding the experiments & the operation of the equipment.Enforced health & safety precautions maintaining a safe/sterile environment. Show less

• 

  Viatris

  Nov 2022 - Mar 2024

  Quality Assurance Executive

  • Certified Internal Auditor with a strong foundation in auditing principles and practices.• Involved in Quality Audits internally & externally with various audit bodies to assess processes, systems& facilities for compliance & areas for improvement.• Lead investigations into product deviations, non-conformances, & critical issues, identifying root causes& implementing CAPAs to address issues & prevent reoccurrence.Assessed the impact of deviations on product quality, safety, & efficacy.• Liaised with Clinical, Manufacturing and Packaging departments as required, coordinating cross functional teams to gather data, conduct interviews & analyse information.• Formulated CAPAs based on the findings of investigations, designing effective action plans to preventrecurrence of deviations, non-conformities & issues leading to complaints. Coordinated theimplementation of CAPAs across relevant departments.• Verified & validated effectiveness of implemented CAPAs to ensure they addressed identified issues.• Ensured that CAPAs & investigations comply with regulatory requirements, GMP & GDP.• Managed & investigated product complaints from customers &/or internal sources identifying rootcauses & implementing CAPAs to address issues & prevent reoccurrence.Evaluated nature & severity of complaints & their impacts on patient safety & product quality.• Liaised with external vendors & market affiliates to determine root causes in complaint investigations.• Managed the reporting of adverse events & product complaints to regulatory authorities.• Reviewed batch records to ensure that products were manufactured & tested in accordance withapproved procedures & specifications to ensure compliance with cGMP & regulatory standards.• Prepared & reviewed SOPs & protocols to ensure compliance with regulatory standards & to reflect current best practices.• Created and analysed data for Quality Metrics. Collated data and presented in KPI/Management review data as required. Show less

• 

  Abbott

  Mar 2024 - Oct 2024

  Quality Engineer/ Quality Analyst

  Prepared Periodic Safety Update Reports (PSURs), Post Market Surveillance Reports(PMSRs) and other required documentation for regulatory authorities. Gathered data from various sources, including product feedback, complaint, quality incidents and field safety corrective action reports, sales, publicly available information and literature review information to compile PSUR and PMS reports. Analysed data using statistical tools and techniques to analyse the data for trends, patterns and potential product issues. Utilized specialized software for data analysis, risk management and report generation including RStudio. Utilized post market surveillance databases including MAUDE, MHRA, MDI and DAEN to track and analyse data. Evaluated the risks associated with identified issues and determine their impact on patient safety and performance. Ensured all post market surveillance activities comply with relevant regulations and standards such as FDA, ISO 13485 and EU MDR. Lead projects aimed at improving the quality of the post market surveillance systems and processes. Maintained detailed and accurate records of all post-market surveillance activities. Show less

• 

  Bristol Myers Squibb

  Nov 2024 - now

  Senior Quality Assurance Specialist Clinical Supply Chain Quality