1201 F. Hoffmann-La Roche AG
QA Manager(m/w/x)
Full-timeOn-siteSenior
Kaiseraugst
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121201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
End-to-end quality oversight for GMP-compliance of systems, including MES and SAP S/4HANA. 5 years QA experience at biologics manufacturing site required. Work with Technical Change Control and CAPA processes.
Requirements
- University degree in life science or engineering
- Minimum of 5 years of experience in Quality Assurance at a biologics manufacturing site
- Practical experience in Quality Oversight for major IT/OT systems
- Practical experience in Technical Change Control, Deviation Management, and CAPAs
- Outstanding communication skills
- Mastery of teamwork in a diverse environment
- Strong acumen across relevant GMP regulations
- Ability to drive quality awareness by integrating regulatory requirements
- Excellent German and English language skills, both written and spoken
- Highly desirable special experience in green field / brown field CAPEX projects
- Implementation of new production or automation technologies
Tasks
- Provide end-to-end quality oversight on GMP-compliance for IT/OT systems
- Ensure GMP-compliance in projects and system lifecycle activities
- Serve as the QA partner for key systems like MES and SAP S/4HANA
- Review and approve GMP records for Technical Change Control and CAPAs
- Coordinate complex deviation investigations and root cause analyses
- Present topics during health authority inspections and internal audits
- Mentor technical experts in inspection preparation and presentation
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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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121201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
End-to-end quality oversight for GMP-compliance of systems, including MES and SAP S/4HANA. 5 years QA experience at biologics manufacturing site required. Work with Technical Change Control and CAPA processes.
Requirements
- University degree in life science or engineering
- Minimum of 5 years of experience in Quality Assurance at a biologics manufacturing site
- Practical experience in Quality Oversight for major IT/OT systems
- Practical experience in Technical Change Control, Deviation Management, and CAPAs
- Outstanding communication skills
- Mastery of teamwork in a diverse environment
- Strong acumen across relevant GMP regulations
- Ability to drive quality awareness by integrating regulatory requirements
- Excellent German and English language skills, both written and spoken
- Highly desirable special experience in green field / brown field CAPEX projects
- Implementation of new production or automation technologies
Tasks
- Provide end-to-end quality oversight on GMP-compliance for IT/OT systems
- Ensure GMP-compliance in projects and system lifecycle activities
- Serve as the QA partner for key systems like MES and SAP S/4HANA
- Review and approve GMP records for Technical Change Control and CAPAs
- Coordinate complex deviation investigations and root cause analyses
- Present topics during health authority inspections and internal audits
- Mentor technical experts in inspection preparation and presentation
Work Experience
- 5 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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
1201 F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
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