Britt Ekman

Background

About Britt Ekman

I have an extensive experience working with QA and IT -management. My speciality is ensuring product and business compliance through digitalisation and automation of the QA processes, Document Management, Quality Control, Validation and Release. I can help customer to set up product information models and IT architcture which can help them to fulfil the requirements in the different product legislations controlling their production. I have worked in controlled industries such as Steel making, Pressure Vessel, Med Tech, Food and Pharmaceutical. I want to help companies and organisations in their digital transformation and I'm combining my long experience with an innovative mind I'm also an experienced IT Service Manager where my focus is to enhance IT Service Management through contionuous improvement methodologies for making ITSM more agile end improve user experience. My key competencies are • Quality control and validation in the business processes • Digitalisation and automation of quality control and validation in the business processes • Traceability, it’s business value and how to ensure it. • Digitalisation and and automation of traceability. • Requirements management through the business chain.(Product requirements and regulations that govern the manufacture of products and relationships with customers • Understanding and knowledge of the central business processes • Business and product information modelling • Integration of PLM, CPQ and ERP tools for optimizing the support of the business and secure quality and compliance. • Document Management an document management tools • ITIL, ISO9001, ISO13485, cGMP and continuous improvement. • PED, ASME, Regulation (EU) 1935/2004), MDR Regulation (EU) 2017/745, BRC8, FDA, cGMP, 21CFR part 11,Eudralex Annex 11