Experience

Fairmed Healthcare

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Jan 2020 - Present

  - Management of the supplier qualification system - Processing and coordination of delimitation of quality agreements / technical agreements with suppliers, service providers and customers - Provision and monitoring of serialisation data for contract manufacturers in TraceLink - Recording and processing of changes (change control), complaints - Participation in inspections by authorities, customer audits, self-inspections - Participation in updating the QM system (e.g. revision of SOPs)



PUREN Pharma GmbH & Co. KG

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consultant Quality Assurance, Product Quality Review

  • Apr 2019 - May 2022

  Preparation and maintenance of periodic Product Quality Reviews (PQRs) for drugs produced for Puren by contract manufacturers Evaluation of contract manufacturer PQRs and internal data (variations, changes, deviations, complaints, recalls) Preparation and maintenance of periodic Product Quality Reviews (PQRs) for drugs produced for Puren by contract manufacturers Evaluation of contract manufacturer PQRs and internal data (variations, changes, deviations, complaints, recalls)



Takeda

• Biotechnology
• 1 - 100 Employee

• Consultant Quality Assurance, Product Quality Review

  • Sep 2018 - Mar 2019

  Supporting tasks for the preparation of Product Quality Reviews (PQRs) Processing the chapters deviations, CAPAs, changes and complaints Supporting tasks for the preparation of Product Quality Reviews (PQRs) Processing the chapters deviations, CAPAs, changes and complaints



Salutas Pharma GmbH

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consultant Quality Assurance, Product Quality Review

  • Nov 2017 - Aug 2018

  Preparation and maintenance of periodic Product Quality Reviews (PQRs) for drugs produced for Salutas by contract manufacturers. Evaluation of contract manufacturer PQRs and internal SAP and Trackwise data (batch overview, changes, variations, deviations, complaints, OOS, recalls, stability data.) Requested PQRs and stability data from contract manufacturers. PQR-training of external employees of the Novartis group. Preparation and maintenance of periodic Product Quality Reviews (PQRs) for drugs produced for Salutas by contract manufacturers. Evaluation of contract manufacturer PQRs and internal SAP and Trackwise data (batch overview, changes, variations, deviations, complaints, OOS, recalls, stability data.) Requested PQRs and stability data from contract manufacturers. PQR-training of external employees of the Novartis group.



HELM AG

• Germany
• Chemical Manufacturing
• 300 - 400 Employee

• Quality Assurance Manager supplier qualification

  • May 2016 - Oct 2017

  Management of the supplier qualification system (Pharma business area). Coordination of GMP aspects in the development of generic drugs in interdisciplinary project teams. Planning, preparation and follow-up of supplier audits and inspections. Coordination of internal / external requests regard supplier qualification. Participated in the actualization of QM systems in the business area Pharma (e.g. SOP revisions). Management of the supplier qualification system (Pharma business area). Coordination of GMP aspects in the development of generic drugs in interdisciplinary project teams. Planning, preparation and follow-up of supplier audits and inspections. Coordination of internal / external requests regard supplier qualification. Participated in the actualization of QM systems in the business area Pharma (e.g. SOP revisions).



NextPharma GmbH

• Germany
• Transportation, Logistics, Supply Chain and Storage
• 1 - 100 Employee

• Quality Assurance Assistent supplier qualification

  • Nov 2014 - Apr 2016

  Supported the planning and execution of supplier audits, including documentation of supplier qualification; staff trainings. Supported customer audits and inspections by authorities (GMP, FDA). Created GMP compliant documentation in quality assurance (SOPs). Performed batch record reviews for clinic samples division. Supported the planning and execution of supplier audits, including documentation of supplier qualification; staff trainings. Supported customer audits and inspections by authorities (GMP, FDA). Created GMP compliant documentation in quality assurance (SOPs). Performed batch record reviews for clinic samples division.



Lichtenheldt GmbH

• Germany
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Employee: Product Quality Review

  • Aug 2012 - Aug 2014

  Creation and maintenance of periodical PQRs for medicinal products in German and English. Reviewed GMP relevant quality documents regarding manufacturing, quality control, techniques etc. Created and maintained statistical evaluations for PQRs. Performed trend analyses; creation and maintenance of PQR offers. Erstellung und Nachhaltung von PQR-Angeboten Creation and maintenance of periodical PQRs for medicinal products in German and English. Reviewed GMP relevant quality documents regarding manufacturing, quality control, techniques etc. Created and maintained statistical evaluations for PQRs. Performed trend analyses; creation and maintenance of PQR offers. Erstellung und Nachhaltung von PQR-Angeboten



medac GmbH

• Germany
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Zeitarbeiter Dokumentenmanagement

  • May 2012 - Aug 2012

  Aufbereitung von Daten zur Meldung an XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) Schulung von Mitarbeitern zur Dateneingabe in XEVMPD Aufbereitung von Daten zur Meldung an XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) Schulung von Mitarbeitern zur Dateneingabe in XEVMPD



Verschiedene in der Landwirtschaft

• Travel&Work, Australien

  • Apr 2009 - Apr 2011

  Sprach- und Arbeitsreise Sprach- und Arbeitsreise



barclaycard

• United Kingdom
• Financial Services
• 700 & Above Employee

• Call Center Agent Inbound

  • May 2008 - Mar 2009

  Kundenservice Kreditkarten Kundenservice Kreditkarten