Managing Consultant

1/2024 – 6/2024

Project management support for the identification, consolidation, planning and visualization of activities concerning Extractable & Leachable risks (USP 665) associated with a diverse portfolio of approximately 150 single-use technologies used by a globally operating vaccines manufacturer.

Technisches Qualitätsmanagement / QS / QA, Compliance management, Projektleitung / Teamleitung

7/2023 – 7/2024

Coordinative and operational support of the internalization of a diverse portfolio of more than 30 single-use technologies currently sourced as ready-to-use systems from external suppliers for a globally operating vaccines manufacturer.

Change-Request-Management, Projektleitung / Teamleitung

6/2022 – 4/2023

Operative support in the preparation, planning and execution of change control requests concerning routine operations as well as various continuous optimization and technology transfer projects for a globally operating vaccines manufacturer.

Change-Request-Management, Projektleitung / Teamleitung

8/2020 – 4/2022

Coordination and assurance of timely compliance qualification activities for approximately 450 incoming materials required for two strategically important technology transfer projects at a globally operating vaccine manufacturer.

Change-Request-Management, Projektleitung / Teamleitung, Technisches Qualitätsmanagement / QS / QA

1/2020 – 6/2020

Subject matter consulting for a globally operating vaccine manufacturer in the consolidation and optimization of its site-wide incoming material control strategy.

Good Manufacturing Practices, Technisches Qualitätsmanagement / QS / QA

1/2019 – 12/2019

Support for a globally operating manufacturer of biopharmaceutical products in establishing a new end-to-end qualification process for externally sourced materials and suppliers.

Good Manufacturing Practices, Technisches Qualitätsmanagement / QS / QA, Projektleitung / Teamleitung

9/2017 – 3/2018

Project management and controlling support of a strategic technology transfer project (OPEX / CAPEX, total volume $ 9.9 M) in an active GMP production environment of a globally acting vaccines manufacturer.

Good Manufacturing Practices, Projektsteuerung (Projektcontrolling)

6/2017 – 12/2019

Systematic analysis and risk-based optimization of the raw material portfolio (approx. 150 chemicals and biologicals) across three active production units of a globally operating vaccines manufacturer.

Good Manufacturing Practices, Technisches Qualitätsmanagement / QS / QA