Birgitte Grønfeldt Uldal

WORK HISTORY

EDUCATION

SKILLS

ABOUT BIRGITTE GRØNFELDT ULDAL

I have worked with quality assurance since 1992, both in the pharmaceutical industry and the medical device business.I am an experienced internal auditor as well as an external auditor of suppliers. Furthermore, I have seven years of QA experience regarding aseptic manufacturing and filling activities including release activities as responsible Qualified Person.I have performed GMP/FDA audits of Medical devices, IVD, and active pharmaceutical ingredient (API) manufacturers, and have a thorough knowledge of manufacturing processes, especially within aseptic and sterile drug processing, packing, labeling, storage and distribution, quality control and quality assurance including releases as a QP. Further I have worked with sterile API and have been a part of building up a sterile micronizing plant.With focus on the implementation of quality management systems I have extensive knowledge of ISO standards, cGMP guidelines and medical device and drug regulations issued by FDA and/or local European medicine agencies.I have prepared, commented and approved validation master plans, project validation plans, qualification and process validations (IQ/OQ/PQ/PV) as well as SOPs.I have been responsible for the education and training of new colleagues internally regarding cGMP issues and aseptic handling. I have given on-site training for customers, and have also been a speaker at European seminars on QA issues in aseptic manufacturing of media to treatment of infertility.Highlights of my qualifications include excellent ability to work with people; commitment to teamwork; and ability to effectively communicate with customers.