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.

Senior Consultant (20+ years) within Medical Device/Life Science Industry.  CSV, Validation Management, QA, ISO 13485, QMS, IT Governance and Management, Validation, Change Management, ERP implementations and Test Management.
 

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.

Worked more than 25 years with Quality and Regulatory in the Pharma (GMP, GDP) and Medical Device (ISO13485, MDD) industry. Experienced in most Quality Assurances processes, including auditing and the responsibilities as Qualifier Person and Responsible Person.

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.
Responsible for certification, CE-marking and registration of Medical Devices outside EU.

Senior Consultant 20+ years of experience within medical device and pharma industries. Leader experience as Production Manager, Project Manager within production as well as R&D as well as Validation Lead. Areas of experience GMP, Change Management, Design Control, Design Transfer, Risk Management, Validation (equipment and computer system) etc.

Senior consultant with over 20 years of experience within the Pharmaceutical, Medical Device and Food/Food supplement industry with focus the last 8 years on Quality Assurance (QA) and Quality Control (QC). Main areas of expertise: QA/QC management, development of Quality Management System (QMS), QA in new product project and Validation.

Senior consultant with 20 years of experience within the pharmaceutical and medical device industry, managing computer system validations and infrastructure qualifications. Main areas of expertise: Computer System Validation, Infrastructure Qualification, Quality Management Systems, SOP development, Data Integrity, Project Management - certified PRINCE 2 practitioner.

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.

Consultant with engineering and management experience within Life Science, Medical Device and Food Industry in areas such as R&D, manufacturing and QA/QC.  Areas of experience ISO 13485, Design Control, Change Management, Validation, Non-conformity Management, GMP manufacturing and product release, GLP laboratory experience within cell and microbiology.

Senior consultant with 20 years of experience within medical device, food, and car industries in areas such as R&D and Manufacturing. Main areas of expertise are Project Management, Design Control, ISO 13485 and Product Development.

Senior Consultant 15+ years of experience within medical device, pharma industry, and more. Leadership experience as group manager, project manager and SME in both R&D and production. Certified practitioner in the Lean problem solving process. Trained and experienced in the Lean production process. Areas of experience: Project management, problem solving, continues improvements, GMP, validation. 

Senior Consultant with 30 + years of experience within industries covering Medical Devices, Manufacturing, Automotive as well as the Pressure Vessel and Energy Sector. Acted as responsible Manager for several large, global companies within the field of QMS, QA, QC, RA and HSE.
Highlights: certifications against the relevant ISO-STDs/regulations, development/improvement of the QMS’s and its processes, Doc Control, Item handling (Incident reporting, Audit reporting, Claim/NC handling etc.), Process mapping, Risk Management, Continuous Improvements and more.

Consultant with 8+ years within the life science industry. Areas of experience include QA, Supplier QA, non-conformance, OOS investigations, Clean room and validation.

Interested in working as a consultant within Life Science? Please contact us for more information!