Flemming Holm-Jensen, Execution Director of FH-International Consulting Co.,Ltd.
Flemming Holm has over 38 years’ working experience in project management, construction management and team building in the Life sciences, Pharmaceutical,, Bio-tech, IVD and Food industries worldwide.
His expertise encompasses Design, Construction, Project Management, Commissioning, Qualification and Validation, including construction site handling for QA verification, Process, Utilities, Systems, Automation and Programming, Staff Training, Facilities and Infrastructure Management and Personnel Development.
Flemming is experienced in every project phase from pre-project and strategic planning, project planning and control, to project handover and post-project evaluation. In particular, he is proficient in commissioning, qualification and validation phases from small to large scale projects, and has strong knowledge of dimensional technical principals, process controls, process validation, GMP, and ISO 9000 standards and requirements.
Duties during the past 38 years are including but are not limited to: project management; compliance management; contractor management; contract open and close in economic standpoint; change control; schedule development; documentation management for FDA inspections; LDI& design coordination and alignment; development of master plans and protocols; commissioning and qualification after construction; validation for factories; management of punch list execution; co-ordination between disciplines, vendors, and contractors; involvement in government permitting issues; tracking the AR/AP status, management of sequence control and quality control; tender and construction documents review; instrument testing and dcs verification; FAT-Mechanical Completion-SAT-CQ-IQ-OQ-PQ-PV.