Senior Consultant with 24 years’ experience from MD and Pharma industries. Main expertise areas: QMS, GMP/manufacturing, CSV, serialization, PM, EDMS, laboratory systems. Certified Lead Auditor.

CSV, Validation Management, QMS, ITQA, IT services, Implementations, Governance and Management. Driven by the responsibility and authority to deliver. Specialties: Deliver on time, IT Service Process, IT Management, QA, Validation, Project Management, Change Control, IT Requirements, ERP implementations, Test Management and SAP.
Medical Device/Life Science Industry/IT (+20 years)

Project Management, LIMS, Payroll, HR systems, Time & Attendance, LIMS, Laboratory systems, Change Management, IT Management, Company IT Integration, Company divestitures, Computer validation, Life Science Industry/IT (20+ years)

Senior Consultant with experience within QMS, internal and external auditing, process and computerized system validation, design validation of medical devices and production equipment and leading, solving and evaluating deviations. Black Belt in Six Sigma.

Senior consultant with 25 years of experience from the Life Science industry ranging from hardware and infrastructure to system development and quality assurance. Main areas of expertise, CSV, Quality Assurance for global projects, Certified Lead Auditor, ISO 9001, GxP, QMS.

Senior Consultant with 20+ years of experience from the MedTech field. QA Manager for Medical Device companies responsible for QA, QC and RA. Other fields of expertise are Design Control, Design Transfer, Risk Management, Computer Software Validation etc.
As QA Manager, responsible for certification, CE-marking and registration of Medical Devices outside EU.

Senior Consultant, who has worked within medical device and pharma industries since 2000. Leader experience as Production Manager within automatic and semi-automatic manufacturing, Project Manager within production as well as R&D as well as Validation Lead.
Areas of experience Good Manufacturing Practice, Change Management, Design Control, Design Transfer, Risk Management, Validation (equipment and computer system) etc.
Master of Science Degree in Chemical Engineering.

Long experience from the pharmaceutical industry (GMP; 21CFR820), Medical Device (ISO13485; MDD/MDR), Food (ISO22000; 21CFR111) with focus on Quality Assurance (QA/QMS) and Quality Control (QC).
My main areas are management support and development of processes within QMS, including experience as validation leader.

Senior Consultant with +10 years of experience within the Quality Organization in the Medical Device and Medicinal Industry. Former QC Manager at Gambro Lundia AB (Baxter). Skilled in Good Manufacturing Practice (EU and US cGMP), Medical Device Quality Management Systems (ISO 13485 and US 21 CFR Part 820), Good Distribution Practice (GDP) and Risk Management (ISO 14971 and ICH Q). Open and social person with a Master's Degree in Chemical Engineering from The Faculty of Engineering at Lund University.
Acting as Qualified Person and Responsible Person at customers.

20 years’ experience of quality/regulatory work in medical device, pharma and API industries, related to validation, design control, document control, change control and operations.
Specialties: equipment and facilities qualifications, validation of processes, test methods and software.

Senior consultant with 20 years of experience within the pharmaceutical and medical device industry, managing computer system validations and infrastructure qualifications through meticulous project execution and exceptional team leadership. Focused IT quality professional dedicated to developing and maintaining, cost efficient, high quality standards with experience from several Quality Management System transition and harmonization projects as part of company mergers and acquisitions. Main areas of expertise: Computer System Validation, Infrastructure Qualification, Quality Management Systems, SOP development, Data Integrity, Project Management - certified PRINCE 2 practitioner.