Marvin Wörner Email & Phone Number

Birsfelden, Bl, Ch

Birsfelden, Basel-Landschaft, Schweiz

Ensuring Compliance: Oversee and ensure the organization's compliance with GMP standards, local laws, and regulations in the context of manufacturing operations.Risk Analysis: Conducting and leading risk analyses related to compliance, including the preparation, documentation, and evaluation of risk analyses associated with the qualification of incubators and single use bioreactors (DQ, IQ, OQ).Qualification of incubators and single use bioreactors: Overseeing the qualification process of facilities and equipment, including Design Qualification (DQ), Factory Acceptance Test (FAT), Site Acceptance Test (SAT) Installation Qualification (IQ), Operational Qualification (OQ), and consulting Performance Qualification (PQ).Collaboration on Projects: Collaborating on various projects related to compliance, providing support to group companies on compliance issues, and contributing to overall compliance reporting.Global Documentation: Contributing to the creation and maintenance of global documentation to manage compliance risks effectively.

Birsfelden, Basel-Landschaft, Schweiz

Als Head of GMP Compliance bin ich bei der Firma Kühner für folgende Aufgabengebiete zuständig:• Erste Anlaufstelle bei Themen Lieferanten- und Geräte-Qualifizierung• Vertritt bei Kunden- Behördenaudits• Koordination und Durchführung von Schulungen• Internes Berichtswesen und Dokumentation-Management• Vorbereitung, Implementierung und Pflege des Qualitätshandbuchs des Unternehmens, um sicherzustellen, dass es die Aktivitäten des Unternehmens widerspiegelt und die gesetzlichen Anforderungen erfüllt.• Sicherstellen, dass die Qualitätsanforderungen der Kunden erfüllt werden• Entwicklung und Implementierung der Qualitätsrichtlinien und -verfahren, um einen ordnungsgemäßen Betrieb des Unternehmens sicherzustellen und die Einhaltung der EU-, US- und ROW-Anforderungen für die Entwicklung und kommerzielle Vorschriften sicherzustellen. • Identifizierung von Möglichkeiten für kontinuierliche Verbesserungen, um die globalen regulatorischen Anforderungen von GxP zu erfüllen.

Birsfelden, Schweiz

Stein

Pharma Inhalation, Subject Matter Expert, Deviation Management, GxP Documentation, Process Optimization, SOP Management, Staff Training, Total Productive Maintenance, Stewardship for assigned products, Risk Management, RCI, CAPA, SAP, AQWA Trackwise, ESOPS, PMX, HSE

Stein

During my internship, I did the following activities• Deviation Management• Yield Optimization• Process Optimization• Responsible for the correct implementation and completion of the documents of the six employees assigned to me• Complaint Management• Risk Management• Pharma Packaging (primary and secondary area)• GxP Documentation• Systems, Applications, and Products in Data Processing (SAP)• AQWA Trackwise• HSE

Eimeldingen

My responsibilities during my employment included creating quotation quotations, complete order processing, handling complaints, such as checking invoices and making customs documents. Furthermore, my tasks included the creation of projects and the responsible maintenance of customer databases.

Bachelor Of Science (Bs), Pharmatechnologie, 4.9 ( Switzerland)

The specialisation in pharmaceutical technology focuses in particular on - Manufacturing of Active Substances - Bioanalysis.

Bürokaufmann, 2.3 (German)

During my education I had the following subjects: - Civics - General Economics - Special Business Administration - Accounting - Data.

Fachhochschulreife, Informations- Und Kommunikationstechnik

The information and communication technology sector is particularly focused on: -Electronics -Programming Technique -Information.