Profilbild von Anonymes Profil, Freelance Quality Assurance Director – Cross-functional Project Lead
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Letztes Update: 20.06.2023

Freelance Quality Assurance Director – Cross-functional Project Lead

Firma: N/A
Abschluss: Dr.rer.nat. - Organische Chemie und NMR-Spektroskopie
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher) | französisch (gut)

Dateianlagen

Profile-Dr_200623.pdf

Skills

  • Freelancing & Consulting Projects up to 6 months – Quality System Design or Improvements.
  • Challenging position as associate director (quality management, R&D, API, pharmaceuticals or medical devices) in a line or project lead function.
  • Leading teams and driving cross-functional harmonizations and improvements.
  • Deployment of quality systems. Development of a quality strategy and its implementation.
  • Business and process re-engineering, GxP-compliance or enhancement projects.
Recent projects
  • Team Lead Quality Management & Systems, business case eQMS investment
  • Quality assurance support (advanced API synthesis)
  • Radiopharmaceuticals manufacturer (QA assessment and remediation recommendations)
  • Inspection preparation, quality system up-grade generics supplier and MA holder – Germany. Implementation of the operational quality risk-management process and definition of remediation projects.
  • Team-Lead Compliance & Documentation (interim management) – Swiss contract manufacturer –supporting buildup of an agile quality organization. Set-up of quality improvements plans (complaints & change control).
  • GCP Presentation – Berlin:  Risk Management & CAPA tools to assure TMF Quality
    International Conference: TMF and Clinical Operations Quality Excellence.
  • QA of API and support analytical R&D – Method Validation/Verification (Protocol Design to Reports); Approval of Reference Standards.
  • Handling of Deviations & CAPA in a consulting project lead by a well-known US consulting organisation.

Projekthistorie

06/2020 - 11/2020
Team Lead Quality Management & Systems. Erarbeitung Business Case für ein eQMS
(Pharma und Medizintechnik, 250-500 Mitarbeiter)


11/2019 - 03/2020
Senior QA Manager (Wirkstoff Entwicklung)
(Pharma und Medizintechnik, 250-500 Mitarbeiter)

QA im Bereich Wirkstoffentwicklung inkl. Batch Record Review, Risikoanalysen, Validierung analytischer Methoden.

Reisebereitschaft

Verfügbar in den Ländern Deutschland, Österreich und Schweiz
Profilbild von Anonymes Profil, Freelance Quality Assurance Director – Cross-functional Project Lead Freelance Quality Assurance Director – Cross-functional Project Lead
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