Mia Winkelmann Email and Phone Number

More than 15 years of experience in the pharmaceutical industry from companies like Novo Nordisk, Leo Pharma, Ferring and Lundbeck working with Automation IT, validation, system administration, IT compliance, Data Integrity and IT & Automation implementation projects. A total of 20 years’ experience as liaison between IT and business bridging user needs to IT solutions, primarily within information management and automation IT. Background rooted in the safety area within pharmacovigilance and developed into implementing, maintaining and decommissioning of the computerised part of automation equipment in production facilities. Has performed the role as System manager within a range of Pharma IT applications.Hands-on experience with preparing, reviewing and ensuring the right level of compliance in documentation and validation of GxP systems with various risk assessments, test protocols, validation deviations, change requests, system descriptions and data flows. Has prepared SOPs and work instructions, executed and reported on testing, concluded on validated state yearly for various automation equipment and participated in a corporate project on Data Integrity (identification, GAP analysis and implementation of mitigating actions). Has worked with both automation (the computerised part of automation systems) and IT within the manufacturing area and has in-depth understanding and respect of GMP. Has a Vault Platform Associate White Belt, is a certified SAFe Scrum Master, has strong communication skills and is good in motivating different stakeholders into cooperation.