Internship in External Quality for Students in Life Sciences
Vor 2 Tagen
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
The Opportunity:
- Provide quality and compliance oversight for external GxP suppliers, including the CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers of analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements.
- Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.
Key Responsibilities:
- Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission) to support the Make, Assess, Release & Deliver (MARD) of commercial and IMP medicinal products.
- Develop, negotiate, and maintain Quality Contracts and Product-Specific Requirements (as appropriate) with GxP suppliers and ensure agreement compliance.
- Collaborate with GxP suppliers to address compliance gaps through Root Cause Analysis, CAPA implementation, deviation reporting and management, escalating as appropriate.
Functional Job Responsibilities:
- Collaborate and manage relationships across End-to-End External Quality Operations and internal cross-functional teams to ensure quality expectations are aligned with Roche's objectives.
- Notify Senior Management of potential quality or regulatory issues impacting product quality or regulatory compliance.
- Timely complete all job-related training requirements before performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology.
Who You Are:
- You are a university student pursuing a Master's degree or have completed a Master's degree in Life Sciences or equivalent within the last 12 months of the start date
- Ability to interpret data effectively and draw conclusions
- Highly competent in MS Office or Google Suite applications, including Excel, PowerPoint, Word, MS Project, etc
- Ability to communicate clearly and professionally both in writing and verbally
- Fluency in oral and written English is a must. German language skills are a plus.
Your application: Please upload your CV and the certificate of your enrolment.
Due to regulations, non-EU/EFTA citizens have to provide a certificate from the university stating that an internship is mandatory and the length of the mandatory internship as part of the application documents.
Do you feel excited? Apply now
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
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Kaiseraugst, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Internship in External Quality for Students in Life Sciences, KaiseraugstClient:Location:Job Category:OtherJob Reference:c0c158fd9f89Job Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:The PositionMission of External QualityWe serve our patients through external partnerships because access to quality...
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