20.06.2023 aktualisiert
100 % verfügbar
Freelance Quality Assurance Director – Cross-functional Project Lead
Oberwil BL, Schweiz
Deutschland +2
Dr.rer.nat. - Organische Chemie und NMR-SpektroskopieSkills
GVPGMPGDPInspektionsplanungremediationRisiko ManagementTeam leadAnalytische ChemieMethodenentwicklung und -validierungProzess Analyse und Optimierung
- 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.
- 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.
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischgut
Projekthistorie
QA im Bereich Wirkstoffentwicklung inkl. Batch Record Review, Risikoanalysen, Validierung analytischer Methoden.