Michael Low Email & Phone Number

A conscientious quality and validation specialist with extensive experience in regulated industry, the majority of these as a software quality/validation specialist managing and supporting a wide range of facility, equipment and software related projects.Six Sigma green belt with extensive experience in Computer System and Equipment validation to regulatory standards including FDA - 21 CFR Part 210, 820, 21 CFR Part 11, ISO13485, GAMP, EudraLex and other European and FDA regulations. Key skills include expert knowledge and guidance in the area of computerised system validation including Quality Management Systems, IT infrastructure, Laboratory systems, ATE equipment, Maintenance Management Systems, Automated Manufacturing equipment and associated software systems including PLC, SCADA and Vision Inspection systems.• Excellent knowledge of GAMP 4/5 framework• Specialist in Computerised Systems Validation, in particular 21 CFR Part 11• Qualified ISO 9001:2000 Lead Auditor, with excellent knowledge of 21CFR 820, Part 11 and European regulations associated with the medical device industry BS EN ISO 13485: 2003 & cGMP• First rate knowledge in all areas of the systems development life-cycle including planning, specification, design, test and implementation• Assessment of new systems for compliance, conducting periodic reviews and reporting on current systems.• Generation of Validation Strategies and Validation Master Plans for large-scale projects, creation of User, Functional and Design Specifications, Test Plans and Test Case, approval of project deliverables.• Conducting Design Reviews and Design Qualification activities• Assisting in the development and execution of Test Protocols including FAT & SAT, IQ, OQ, PQ etc.• Experienced in developing and executing test strategies.• Generating periodic system reviews and gap analysis plans for legacy equipment and remediation activities to data integrity standards.• Proficient in writing Standard Operating Procedures (SOP) and Work Instructions (WI)

Listed skills include Fda, Quality System, Validation, Gxp, and 14 others.