Quality Support @ Responsibilities included; quality oversight, review and approval for all site validations, Internal Auditing, Validation training and mentoring, Change Control and CAPA quality approvals, Document Control approval and issuance. QA representative for the implementation of a small and large scale projects providing compliance oversight. Validation types include Computer Systems, Production Equipment, Laboratory Systems, Cleaning, Media
Quality Support @ Responsibilities included; quality oversight, review and approval for all site validations, Internal Auditing, Validation training and mentoring, Change Control and CAPA quality approvals, Document Control approval and issuance. QA representative for the implementation of a small and large scale projects providing compliance oversight. Validation types include Computer Systems, Production Equipment, Laboratory Systems, Cleaning, Media Fills, Buildings & Facilities, Process, Methods and Re-Qualifications. From March 2011 to October 2015 (4 years 8 months) Validation SME @ Participated on corporate and divisional teams for validation excellence, leading a cross site synergy project on validation, delivering a site validation structure, overseeing site validations, preparing and delivering validation training modules.
Responsibilities included; preparing and executing validations for process, clean room and inspection equipment.
Validation types include Computer Systems, Equipment, Buildings & Facilities, Process and Methods.
As calibration supervisor I had direct oversight of a team of calibration technicians, approval of all calibrations and reporting of metrics to management. From March 2008 to April 2011 (3 years 2 months) Automation Validation @ Project involved the provision and development of an Emerson DeltaV Process Automation System (PAS) for a biopharmaceutical facility in Sweden (approx. 5,000 I/O).
Responsibilities include; deputising for the Validation Lead as required, compiling daily stats reports, overseeing a team of validation engineers on the preparation of Software Module Test Specifications, preparation of FAT protocols, formal review of post execution FATs and preparation of summary reports. This role involved direct communication with the client on a daily basis. From October 2007 to March 2008 (6 months) Validation Consultant @ Approval of all Automation, Engineering, Computer Systems and Analytical validation documentation. Conducting Quality Audits both internally and vendor audits. Delivering Compliance training. QA lead on an ABB control system upgrade. QA representative for the implementation of a several Global systems (ERP, MES).
Representing Centocor Cork on the Global Compliance Forum Team; contributing to corporate compliance validation guidelines; development, deployment and training on a local Computer Systems Validation Methodology; conducting Risk Assessments and developing SOPs and Templates; development and implementation of a local Change Management Solution; IM representative for validation teams for LIMS, SDMS, SAP, 21CFR Part 11, Change Control, Event Management.
Site Business Lead for a Global Electronic Document Management System (Documentum). Development and delivery of site wide user training. Local validation of Global Event Management System (Trackwise).
Quality Systems Validation Specialist developing a Laboratory Validation Master Plan (LVMP); co-ordinating vendor validation packages and vendor selection; training analysts in validation techniques; preparation of validation documents for QC Analytical Systems.
Major projects included: 21 CFR Part11 for the Laboratories, CSVIT Methodology, CompuCal Upgrade, LAN Infrastructure, SAP Upgrade, ELSA design and implementation
Development, deployment and training on a local Computer Systems Validation Methodology; overseeing a multidisciplined professional team; developing SOPs, templates and producing an on-line Audio Visual Training Package.
Systems Administrator for Laboratory systems; preparation and implementation of Security Plans and SOPs to bring systems in line with the 21 CFR Part11 ruling. Validation of a major SAP upgrade that included site cross-functional teams and external consultants. From April 2001 to October 2007 (6 years 7 months) Consultant @ From 2006 to 2006 (less than a year)
Industrial Instrumentation, Physics @ Galway-Mayo Institute of Technology From 1995 to 1998 Marie Kirk is skilled in: Validation, GAMP, GMP, Computer System Validation, V&V, Change Control, Visio, Analytics, Automation, Disaster Recovery, Microsoft Excel, FMEA, Graphics, ISO, Internal Audit
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