Terry McMahon
Csv Engineer @Fresenius Kabi
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WORK HISTORY
Csv Engineer @Fresenius Kabi
Warrington, GB
Quality Risk Management Moderator. Part of a team to maintain the Validation Master Plan (VMP), inclusive of the Dynamic Plan and update the Validation life-cycle of Items on the site VMP. Created Validation training strategy for Computer System Validation. Member of the Change Control, Risk Management, data governance and System Identification Process teams. Site lead for system application testing for the introduction of Office 365 and Windows 10. Identified and led a Risk based approach for continuing use of Windows 10, Office 365 and Security applications. Gap analysed the current VMP computer system list and outstanding activities to help formulate a risk based CSV program.(2018). Managed system owners, process owners, data owners and subject matter expert to bring together and understanding of responsibilities and validation requirements and report on CSV Program KPI\'s.Validation Work stream lead for the introduction of an additional SAP warehouse type and the introduction of inter-warehouse movement transactions / functionality. 2018 Working as part of a team to validate a Core Manufacturing System for compounding intermediates and finished products. Have written a 5-phased Training Programme SOP and supporting training documents (i.e. Role Specific SOPS and Competency Assessments, instructor led training, including issue escalation process, training videos, training exercises, process training and training review) to support introduction of Manufacturing System. Have written computer systems life cycle SOPs and to support the running and administration of Manufacturing System. Written specifications, and software validation protocols for Quality, Manufacturing and site systems as part of the GAMP life-cycle approach. Introduced a risk based approach (Initial Quality Triangle) impact assessment to define initial impact on the QMS to site from either the business (New Product Introduction), Corporate impact, Regulatory and New Knowledge.
EDUCATION
The Open University
pass, Chemistry
The Open University
Higher National Diploma, Chemistry
ABOUT TERRY MCMAHON
Specialties: Scientist with wide knowledge of installing local and global computer systems from; LIMS, both QA/QC modules of LabWare and LabVantage (Additionally ELN\'s for scientific formulation experiments), Environmental Monitoring Systems, SAP (New Warehouse and interfaces) and Quality Management Systems. Quality Risk Management Moderator.Very strong knowledge of both Equipment and Software Validation. Good knowledge of Project Management (Prince 2) used locally and on a global platform. Have written a full FDA CSV Life-cycle approach inclusive of new FDA guidance on CSA.Wide knowledge of crystalline and amorphous Finished, Semi-Finished solid dose (wet and dry powder granulation and liquid fill) manufacture. Expertise is in Roller Compaction, Spray coating of Tablets, Tablet compression and Technical transfers. Good knowledge of characterisation of blends/API’s. Many skills in Identity testing, dissolution, many wet chemical techniques including HPLC. Fully GMP trained in both Sterile and non Sterile areas. Set up and Maintained Stability studies on paper as well as built in LIMS.
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