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.

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.

Senior Consultant with 25+ years of GMP experience.
Experienced QA IT / CSV QA, with a high level of knowledge of Data Integrity and GMP - FDA regulations CFR Part 211 and Part 11, EU regulations Eudralex volume 4 and Annex 11, and the industry guideline GAMP5.

Senior consultant with 20 years of experience from the Pharma field (GMP) with focus on R&D and the last half of the career on QA (Quality Assurance). Experienced in most QA processes such as development of QMS and responsibility as QP (Qualified Person) for release of both commercial products and IMPs for clinical trials. Other knowledge areas are MDR (ISO13485) and quality/regulatory requirements for medical devices.

Senior Consultant with 20 years’ experience from R&D in the pharmaceutical industry and development of medicinal products including scale up, tech. transfer and process validation. Several years in a manager role with responsibility for a formulation group, pilot plant, equipment and media as well as internal and outsourced formulation developments

Katja has 5 years of experience from the pharmaceutical industry with focus on QA (Quality Assurance) and QC (Quality Control). Her area of experience includes batch release of starting materials, non-conformance and handling of CAPA, Change Control, Supplier Evaluation and Implementation of analytical methods. She also has several years of experience as R&D engineer.

+5 years of experience in Life Science and diagnostic ISO 15189 laboratory environments. Expertise in quality management, deviations, and document handling in QMS, as well as QA, which has been obtained in roles as Quality Assurance Specialist, Quality Coordinator and Biomedical scientist.

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