F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Full-timeOn-siteSenior
Basel
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Validation of sterile drug product processes in technical transfer teams at global pharma company. BS/BA in life sciences or engineering with multiple years of bio/pharmaceutical experience required. Work in high-performance learning culture.
Requirements
- BS/BA degree in life sciences or engineering
- Advanced degree favorable
- Multiple years of relevant bio/pharmaceutical experience
- Experience ideally in manufacturing, process validation, or technical development
- In-depth practical experience in high-performance learning culture
- Fundamental understanding of safety, quality systems, quality assurance concepts
- Understanding of cGMPs
- Ability to work in self-organized, multi-disciplinary team
- Ability to work in agile environment
- Sense of urgency
- High motivation
- Track record of driving change
- Strong communication and collaboration skills with diverse stakeholders
- Solution-oriented 'can-do' attitude
- Mindset focused on organizational success
- Fluency in German and English
Tasks
- Validate sterile drug product processes in technical transfer teams.
- Manage validation process and product lifecycles.
- Develop and improve local/global validation strategies.
- Address product hold time and time out of storage strategies.
- Collaborate with partners on validation strategy development.
- Troubleshoot sterile manufacturing processes.
- Drive continuous improvement initiatives.
- Manage quality risks.
- Manage PQS elements: Change, CAPA, Deviation.
- Collaborate with functions across the Roche/Genentech network.
- Author regulatory dossier sections.
- Support regulatory strategy implementation for product launches.
- Design robust validation processes using Agile and LPS.
- Leverage cutting-edge technology for validation processes.
- Maintain understanding of sterile manufacturing, GMP, and regulations.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- cGMPs
- agile
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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Validation of sterile drug product processes in technical transfer teams at global pharma company. BS/BA in life sciences or engineering with multiple years of bio/pharmaceutical experience required. Work in high-performance learning culture.
Requirements
- BS/BA degree in life sciences or engineering
- Advanced degree favorable
- Multiple years of relevant bio/pharmaceutical experience
- Experience ideally in manufacturing, process validation, or technical development
- In-depth practical experience in high-performance learning culture
- Fundamental understanding of safety, quality systems, quality assurance concepts
- Understanding of cGMPs
- Ability to work in self-organized, multi-disciplinary team
- Ability to work in agile environment
- Sense of urgency
- High motivation
- Track record of driving change
- Strong communication and collaboration skills with diverse stakeholders
- Solution-oriented 'can-do' attitude
- Mindset focused on organizational success
- Fluency in German and English
Tasks
- Validate sterile drug product processes in technical transfer teams.
- Manage validation process and product lifecycles.
- Develop and improve local/global validation strategies.
- Address product hold time and time out of storage strategies.
- Collaborate with partners on validation strategy development.
- Troubleshoot sterile manufacturing processes.
- Drive continuous improvement initiatives.
- Manage quality risks.
- Manage PQS elements: Change, CAPA, Deviation.
- Collaborate with functions across the Roche/Genentech network.
- Author regulatory dossier sections.
- Support regulatory strategy implementation for product launches.
- Design robust validation processes using Agile and LPS.
- Leverage cutting-edge technology for validation processes.
- Maintain understanding of sterile manufacturing, GMP, and regulations.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- cGMPs
- agile
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Roche and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
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