Im Bereich Freelancing
2022-06
2022-12
Verhandlung von einem QTA -Backlog
2017-09
2021-05
Managed all ISO 9001, GMP and GDP licenses for the alliance and the clients from submission to recertification or withdrawal. Prepared registration documentation for clients. (clients from small Generic Companies with couple products to Global Pharma companies with more than 700 actives/ 8000 + MAs, registered globally including biosimilars or vaccines). Successfully obtained marketing authorizations for clients? products.
· Preparation of registration documentation. Lifecycle management for medicinal products. Maintaining SmPC and PIL in line with EU-registered products.
· Preparation and coordination of all SOPs. Management of GMP and GDP licenses of Pharmazet Alliance and its clients. Preparation for audit and inspections internal as well as external. Tracking all training schedules.
· Sampling incoming imported medicinal products.
2016-01
2017-08
· Manufacturing DCVAC in a clean lab (GMP)
· Preparation of media for production in the clean lab
· Administration of manufacturing protocols (GMP)
· Distribution of DCVAC for application
2017-10
2018-06
2013-01
2015-01
2010-01
2013-01
Ensures QMS support in all areas from writing to implementing SOPs, to training materials and the entire lifecycle management. QAA Negotiations, Change Control Management, Deviation investigation, and CAPA follow-ups. Interim Management of critical situations and guidance from a QP Perspective to support Clients? needs
· Eliminated causes of non-conformities and other undesirable situations through CAPA Management.
· Implementation of GxP requirements to ensure that pharmaceutical products are safe, meet their intended use and adhere to quality processes during manufacturing, control, storage, and distribution.