Senior Quality Assurance Manager for ISO13485:2016, ICHQ10, GMP, GDP, GAMP
Aktualisiert am 16.05.2024
Profil
Mitarbeiter eines Dienstleisters
Remote-Arbeit
Verfügbar ab: 16.05.2024
Verfügbar zu: 100%
davon vor Ort: 50%
Skill-Profil eines fest angestellten Mitarbeiters des Dienstleisters
German
Muttersprache
English
Verhandlungssicher

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2 years 7 months
2021-11 - 2024-05

Consultant: Project Manager ICHM7/ Nitrosamines/ NDSRI

Project Manager ICHM7/ Nitrosamines/ NDSRI agiles Projektmanagement Good Manufacturing Practice
Project Manager ICHM7/ Nitrosamines/ NDSRI
Pharmaceuticals Healthcare Medizinprodukte
agiles Projektmanagement Good Manufacturing Practice
Sanofi-Aventis Deutschland GmbH
Remote
4 months
2023-02 - 2023-05

Consultant: Deputy Project Lead und Compliance Expert

Deputy Project Lead und Compliance Expert agiles Projektmanagement Computerized System Validation
Deputy Project Lead und Compliance Expert
  • Deputy Project Manager to ensure and adhere to the given time and budget planning
  • Supportive function for the Audit Readiness program
  • Supervise project tasks related to validation of computer systems in Enterprise Resource Planning System and other functional areas
  • Provide the necessary training and conduct information sessions to effectively communicate the validation program to the project team members
Pharmaceuticals
agiles Projektmanagement Computerized System Validation
BA. Unternehmensgruppe (BA.-Service, BA-Herstellung)
Remote
9 months
2021-04 - 2021-12

Consultant: Quality Manager

Quality Manager MDR/ IVDR ISO13485:2016 Good Manufacturing Practice
Quality Manager
  • Development and integration of a quality management system in accordance with ISO13485:2016 and cGDP standards
  • Preparation and processing of technical documentation for the approval of in-vitro diagnostic tests (class D) in accordance with IVDD 98/79/EC and IVDR 2017/746
  • Supplier qualification in accordance with cGMP and cGDP specifications
  • Project management of the various suppliers and review of documentation, as well as initiation of required measures
  • Reporting and preparation of summary to the management
In-Vitro Diagnostics Class D
MDR/ IVDR ISO13485:2016 Good Manufacturing Practice
X1 Pharma GmbH + Pharmact AG
Remote / Mannheim

Kompetenzen

Kompetenzen

Qualitätssicherung

GMP
GDP
Medical Devices

Branchen

Branchen

Pharma, Biotech, Medtech

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

2 years 7 months
2021-11 - 2024-05

Consultant: Project Manager ICHM7/ Nitrosamines/ NDSRI

Project Manager ICHM7/ Nitrosamines/ NDSRI agiles Projektmanagement Good Manufacturing Practice
Project Manager ICHM7/ Nitrosamines/ NDSRI
Pharmaceuticals Healthcare Medizinprodukte
agiles Projektmanagement Good Manufacturing Practice
Sanofi-Aventis Deutschland GmbH
Remote
4 months
2023-02 - 2023-05

Consultant: Deputy Project Lead und Compliance Expert

Deputy Project Lead und Compliance Expert agiles Projektmanagement Computerized System Validation
Deputy Project Lead und Compliance Expert
  • Deputy Project Manager to ensure and adhere to the given time and budget planning
  • Supportive function for the Audit Readiness program
  • Supervise project tasks related to validation of computer systems in Enterprise Resource Planning System and other functional areas
  • Provide the necessary training and conduct information sessions to effectively communicate the validation program to the project team members
Pharmaceuticals
agiles Projektmanagement Computerized System Validation
BA. Unternehmensgruppe (BA.-Service, BA-Herstellung)
Remote
9 months
2021-04 - 2021-12

Consultant: Quality Manager

Quality Manager MDR/ IVDR ISO13485:2016 Good Manufacturing Practice
Quality Manager
  • Development and integration of a quality management system in accordance with ISO13485:2016 and cGDP standards
  • Preparation and processing of technical documentation for the approval of in-vitro diagnostic tests (class D) in accordance with IVDD 98/79/EC and IVDR 2017/746
  • Supplier qualification in accordance with cGMP and cGDP specifications
  • Project management of the various suppliers and review of documentation, as well as initiation of required measures
  • Reporting and preparation of summary to the management
In-Vitro Diagnostics Class D
MDR/ IVDR ISO13485:2016 Good Manufacturing Practice
X1 Pharma GmbH + Pharmact AG
Remote / Mannheim

Kompetenzen

Kompetenzen

Qualitätssicherung

GMP
GDP
Medical Devices

Branchen

Branchen

Pharma, Biotech, Medtech

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