Experience

Cruinn Diagnostics

• Ireland
• Hospitals and Health Care
• 1 - 100 Employee

• Interim Assistant Quality Manager

  • Jan 2023 - Present



APC

• Ireland
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Officer

  • Sep 2021 - Jan 2023

  Quality Management System: • Develop, enhance and maintain the Quality Assurance programme to meet best in class standards. • Responsible for record management for Quality related documents e.g. reports, protocols, SOPs, training, , process qualification. • Ensuring all SOPs, forms, logs, protocols and summary reports are completed and reviewed against Quality standards. Issue laboratory notebooks and equipment logbooks as required. • Supporting the development and implementation of QMS programme across the organisation. • Ensuring that all quality SOPs and programmes are adhered to and are regularly reviewed and updated. • Preparing Quality compliance metrics. • Ensuring that all CAPAs and deviations are documented and investigated. • Managing of Change Control requests. Audit Readiness: • Providing subject matter expertise to Technical Operations on various Quality related topics. • Supporting external Quality audits with co-ordination of audit activities and action plans. • Conducting internal Quality audits e.g. walk through audits, system audits, report issuance, CAPA follow-up and closure. Ensuring that follow-up actions are completed. • Ensuring compliance of Quality and use analytics to measure compliance across the organisation. • Establishing a structured programme of Quality training across the organisation. • Facilitating ‘as is’ mapping and root cause analysis. Use continuous improvement tools to instigate actions for improvements. Collaboration & Engagement: • Providing Quality oversight for assigned projects within Technical operations. Actively participate in projects by attending meetings (internal and external) and project updates, perform quality review of laboratory notebooks, technical data and the final technical report and contribute to and participate in the After Action Review (AAR) meetings. • Preparing and delivering quality training materials to colleagues. • Collaborating with HR & Training on LMS and training activities. Show less



Cruinn Diagnostics

• Ireland
• Hospitals and Health Care
• 1 - 100 Employee

• Quality & Microbiology Analyst

  • Jun 2020 - Sep 2021

  Quality: ● Managing non-conforming processes and conducting CAPA investigations ● Reviewing and verifying of testing certificates and documentation submitted by other departments. - attention to detail being key ● Meeting targets and deadlines reviewing documents (3 day SLA) ● Managing and notifying customers of product/machinery updates ● Liaising with customers with regards to testing schedules, and maintaining day to day email correspondence ● Performing reviews and generation of company SOPs and controlled documentation ● Handling of change control requests ● Liaising with operational managers with daily reports, highlighting issues and customer queries ● Conducting day to day liaisons with operational teams to ensure all SLA’s are met and a quality service is provided ● Dealing effectively with customer complaints and escalating cases where necessary ● Offering support and guidance via internal emails, updating work items, answering general queries ● Conducting Process based Risk assessments Microbiology: ● Environmental Monitoring testing in Client Grade C/D cleanrooms, Validation of Client cleanrooms and analysis of testing results. ● Daily and efficient reporting of patient testing results, in collaboration with HealthWatch. ● Growth promotion testing of microbiological culture media, in accordance with customer specifications. ● Microbial identification and gram staining of bacterial isolates. ● Inoculum preparation and maintaining in-house and external isolates. Show less



Enfer Group

• Ireland
• Executive Offices
• 1 - 100 Employee

• QC Microbiology Analyst

  • May 2019 - May 2020



VUE Cinemas

• Customer Assistant

  • Oct 2016 - May 2019

  ● Training and mentoring of new employees ● Daily communication with customers to ensure excellent customer satisfaction ● Handling of customer complaints and processing of refunds ● Training and mentoring of new employees ● Daily communication with customers to ensure excellent customer satisfaction ● Handling of customer complaints and processing of refunds