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Work Selection AG

1 year ago

GMP Compliance Manager (m/w/d)

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Company information

Company
Work Selection AG
Location
Schweiz, Kanton Basel-Stadt, Basel-Stadt, Basel Switzerland
Posted
1 year ago
View all jobs at Work Selection AG

Job description

Work Selection AG For our renowned business partner, F. Hoffmann-La Roche in Basel, we are looking for a motivated and engaged GMP Compliance Manager for a fixed-term engagement of one year with the option to extend. As part of the dynamic team, the GMP Compliance Manager will act as the central interface between various production and support departments. They will be the first point of contact for all compliance topics and play a key role in shaping and innovating material supply. Through close cooperation with cross-functional colleagues, there is the opportunity to significantly shape and improve GxP compliance processes. Tasks - Maintaining and deepening GxP Compliance culture within Materials Supply Chapter and Materials Management - Sensitizing, coaching, and supporting SMEs on GxP Compliance and process improvement topics - Tracking and expanding compliance-relevant KPIs and annual goals at MM LT level for the Compliance department - Handling and supporting deviations and conducting root cause analyses, as well as implementing corrective or preventive measures - Handling and supporting changes and implementing necessary measures - Planning, handling, and implementing technical changes within Materials Management - Planning, handling, and implementing project work in the GMP environment - Preparing, participating, and representing the department at internal and external audits & inspections - Re-establishing, revising, and reviewing GMP documents - Re-establishing and optimizing risk analyses, as well as serving as a contact person for the Materials Management department on QRM topics - Establishing and conducting training in the Materials Management department - GMP-compliant conception of new and existing workflows - Deviation, CAPA, and change management (Deviation/UPE and PE management) - Representing the department at internal and external inspections Requirements - Bachelor's degree in Life Science or Engineering, or equivalent education with comprehensive practical experience in the technical processes of the pharmaceutical industry - Minimum 3 years of professional experience in the cGMP environment, particularly in implementing cGMP requirements - Professional experience in Quality Assurance or Quality Control - First-hand experience in handling and operating automated systems in chemical or biotechnological development and production - In-depth knowledge of the process within one's area of responsibility - Excellent verbal and written communication skills in German and English are required - Teamwork ability - Building a trusting and effective relationship with interfaces - Responsibility for decision-making on the above-mentioned tasks and activities Have we piqued your interest? Don't hesitate and submit your complete application documents to us today. We look forward to hearing from you! We value diversity and welcome all applications ? regardless of gender, social background, religion, age, and identity. For easier readability and better understanding, we only use one gender form. Of course, all gender forms are equally intended in their respective context. Temporary 100% employee Industry: Other Function: Other

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