Ulrike Reuter

Ulrike Reuter has been working for Sanofi-Aventis since 1989 in different technical positions. As an engineer in a pharmaceutical company, she strives to reconcile technical and GMP requirements. She is currently working on implementing the new Annex 15, Annex 11 and other technical GMP issues as part of operational support and project management.

After graduating in Mechanical Engineering in Darmstadt, Ulrike Reuter started her professional career in facility planning at Hoechst AG in 1989. Her tasks included the role of project manager for a continuous solid-state condensation facility in Guben (Brandenburg).

After working as an operations engineer in antibiotics manufacturing, she was responsible for the creation of a technical compliance group for the Sterile Medicinal Products department. She took on further responsibilities in the area of project management, qualification and technical regulations in 2010.

In 2016 she was appointed to IS-RMH (Information Security Risk Manager Head) and participates in this context also in B3S (Industry-specific safety standard).

In 2021, the scope of responsibilities has changed and Ulrike Reuter has taken over the management of the Shared Services Maintenance group.

She is author or co-author of the following chapters of GMP Compliance Adviser:

6.B Activities for the preparation of a qualification
6.D Design Qualification (DQ)
6.E Installation Qualification (IQ)
6.F Operational Qualification (OQ)
6.G Performance Qualification (PQ)
6.H Qualification by third party
6.I The qualification life cycle

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