Qualitätsmanger, Sachkundige Person, cGMP Experte, Auditor

4/2020 – 12/2021

Leading the Quality UnitLeitung der Qualitätseinheit
QP Release of vaccines
Management of Health Authority Inspections (local and international, incl. FDA)
Implementation of bicohemical analytical capacity
Implementation of a LIMS for environmental monitoring
Acquisition and support of customers
Management of customer audits
Substitute for the General Manager

Good Manufacturing Practices, Management (allg.), Qualitätssicherungssysteme

9/2018 – 4/2020

Leading the Quality Unit for marketed products and clinical trial material (including release responsibility)
Product Portfolio: liquid and lyophilised parenterals, aseptically produced
Portofolio: about 1/3 of the revenue of the Janssen group
Management of Health Authority Inspections: Swissmedic, FDA

Good Manufacturing Practices

11/2016 – 8/2018

Managing the complaint investigation process globally
Continuous improvemet of the global complaint handling process
Presenting the complaint handling process during global Health Authority Inspections (EMA, FDA)

Good Manufacturing Practices

4/2014 – 10/2016

- Leading the Site Quality Unit
- Responsible Person, QP release of products
- Production of vaccine API and drug product
- Change Management
- Single Point of Contact for Health Authority
- Management of Health Authority Inspections (local and internationl, incl. US)

Good Manufacturing Practices, Management (allg.)

12/2011 – 3/2014

- Consultancy and auditing of internal and external (CMO) sites in Europa, US and Asia regarding GMP compliance
- Management and support of Health Authority Inspections (EMA, FDA)

Good Manufacturing Practices

10/2011 – 11/2011

- leading the QM Unit at a manufacturer of dosing systems for the use in pharmaceutical and cosmetic products.

Good Manufacturing Practices

4/2011 – 9/2011

- Support of the local operating comapnies regarding quality management
- Focus: Complaint Handling and Management Review

Good Manufacturing Practices