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Michael Holt

Consultant

IT & Automation / GAMP
GMP
Facilities & Equipment Validation
Computer System Validation

Michael is a consultant within GMP IT and Automation as well as medical equipment. Michael is a graduate engineer in Health Technology from AAU, and he subsequently worked as a researcher in basic pain mechanisms at the Center for Sensory-Motor Interaction (SMI), which involved designing and performing experimental humane pain studies.

Michael has quickly gained experience within a number of areas in the pharmaceutical industry. These included packing lines, formulation, filling and serialisation of packing materials, domestically and abroad. The tasks involved the preparation of most validation documents, from FAT/SAT to final reports such as XQR/VPR, as well as participation in the performance of tests and qualifications. Currently, Michael’s work includes project coordination and management of projects involving migration of process equipment and procurement of equipment for purification processes.

Michael’s experience with cooperation within the pharma industry is thus professionally and geographically broad. He therefore has a particularly solid grasp of work processes and validation procedures. Michael continues to gain experience with the creation, management and performance of change cases, and alongside his consultancy work, he is attending a course to become a PEM-certified project manager.

“I am very analytic and systematic in my approach to all my work – whether day-to-day, long-term, private or professional. My starting point is a positive attitude towards people and tasks, and I am motivated on a daily basis by results, meeting deadlines and good, positive cooperation. My strengths include loyalty and involvement, which enable me to always strive to produce flawless work. Both in regard to deadlines and to the quality of the content. When I find myself outside my area of expertise, I do not hold back from acquiring knowledge on my own or asking colleagues for help.