Senior Quality Consultant
More about Anita
Anita Gade holds a Master of Science in Chemical Engineering from the Danish Technical University in year 1992.
Anita has extensive experience working with the Medical Device and Pharma Industry for +20 years. She has worked within the areas Quality Management and Compliance and thus has a solid experience with Manufacturing of Active Pharmaceutical Ingredients, Medical Devices and Finished Goods and Warehouses.
Anita can offer business consulting to comply with ISO13485, ISO 9001 standards, Medical Device Directive 93/68/EEC, Medical Device Regulation 2017/745, and US FDA QSR title 21 Code of Federal Regulations part 820.
Anita possesses an examined ISO Lead Auditor background and, thus, she has obtained solid experience with Internal-, Supplier- & Contract Manufacturer Audits.
Further, she has experience and skills within Operations e.g. Root Cause Analysis, Nonconformity, Corrective and Preventive Actions, Change Control, GMP and GDP, Training, Aseptic Manufacturing, Validation Documentation, Supplier Management, Preparation of Quality Agreements, Implementation/maintenance of Quality Management Systems, Process optimization.