ten23 health
QA for QC Expert(m/w/x)
Full-time/Part-timeOn-siteExperienced
Basel
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F.F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Technical quality oversight for manufacturing assets, medical devices, and combination products in aseptic pharma/biotech production. Over 10 years in pharma/biotech quality engineering with aseptic manufacturing and medical device expertise required. Standardizing manufacturing assets through rigorous lifecycle management.
Requirements
- Bachelor's or Master in Life Sciences, Engineering, or Chemistry
- Over 10 years experience in quality engineering (pharma/biotech manufacturing)
- Proven track record in aseptic manufacturing
- Expertise in medical devices and combination products
- Deep technical expertise in asset/equipment qualification (device/combination product manufacturing)
- Strong background in preventive maintenance, calibration, critical utilities management (GMP, FDA, EMA)
- Strong communication and interpersonal skills
- Ability to work collaboratively across multiple sites
- Ability to clearly convey technical information
- Proven experience in managing cross-functional projects
- Experience with standardization initiatives and quality improvement programs
- High attention to detail
- Commitment to highest quality standards
- Proficiency in English
- German language skills (plus)
Tasks
- Execute technical quality oversight across the manufacturing network
- Maintain compliance, reliability, and inspection readiness for manufacturing assets
- Standardize manufacturing assets through rigorous lifecycle management
- Ensure all engineering requirements are met
- Collaborate with Site Quality and cross-functional partners
- Maintain technical integrity of equipment throughout its lifecycle
- Ensure compliant, efficient, and high-performing manufacturing solutions
- Provide high-level technical support to PTM, PTT, and manufacturing sites
- Ensure completion of Quality deliverables
- Act as Quality Single Point of Contact (QSPOC)
- Provide technical quality oversight for device and packaging projects
- Ensure cohesive qualification of device and combination product assets
- Ensure cohesive calibration of device and combination product assets
- Provide quality input for capital projects
- Contribute to greenfield projects
- Support facility design, qualification, and validation activities
- Design fit-for-purpose manufacturing systems
- Ensure compliant and efficient manufacturing systems
- Establish GMP oversight aligned with internal policies and external regulations
- Proactively mitigate risks through early engagement
- Provide technical quality oversight for medical device pilot plants
- Support strategies for comprehensive maintenance programs
- Ensure reliable operation of equipment, utilities, and systems
- Monitor effectiveness of maintenance programs
- Recommend technical improvements for maintenance
- Oversee qualification of equipment and utilities to regulatory standards
- Ensure ongoing compliance throughout the operational lifecycle
- Establish monitoring strategies for standardized calibration programs
- Ensure data integrity through calibration programs
- Manage complex non-conformances in calibration
- Provide technical oversight for critical utilities (HVAC, water, air, steam)
- Ensure critical utilities meet quality and regulatory performance standards
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP
- FDA
- EMA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 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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F.F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
Technical quality oversight for manufacturing assets, medical devices, and combination products in aseptic pharma/biotech production. Over 10 years in pharma/biotech quality engineering with aseptic manufacturing and medical device expertise required. Standardizing manufacturing assets through rigorous lifecycle management.
Requirements
- Bachelor's or Master in Life Sciences, Engineering, or Chemistry
- Over 10 years experience in quality engineering (pharma/biotech manufacturing)
- Proven track record in aseptic manufacturing
- Expertise in medical devices and combination products
- Deep technical expertise in asset/equipment qualification (device/combination product manufacturing)
- Strong background in preventive maintenance, calibration, critical utilities management (GMP, FDA, EMA)
- Strong communication and interpersonal skills
- Ability to work collaboratively across multiple sites
- Ability to clearly convey technical information
- Proven experience in managing cross-functional projects
- Experience with standardization initiatives and quality improvement programs
- High attention to detail
- Commitment to highest quality standards
- Proficiency in English
- German language skills (plus)
Tasks
- Execute technical quality oversight across the manufacturing network
- Maintain compliance, reliability, and inspection readiness for manufacturing assets
- Standardize manufacturing assets through rigorous lifecycle management
- Ensure all engineering requirements are met
- Collaborate with Site Quality and cross-functional partners
- Maintain technical integrity of equipment throughout its lifecycle
- Ensure compliant, efficient, and high-performing manufacturing solutions
- Provide high-level technical support to PTM, PTT, and manufacturing sites
- Ensure completion of Quality deliverables
- Act as Quality Single Point of Contact (QSPOC)
- Provide technical quality oversight for device and packaging projects
- Ensure cohesive qualification of device and combination product assets
- Ensure cohesive calibration of device and combination product assets
- Provide quality input for capital projects
- Contribute to greenfield projects
- Support facility design, qualification, and validation activities
- Design fit-for-purpose manufacturing systems
- Ensure compliant and efficient manufacturing systems
- Establish GMP oversight aligned with internal policies and external regulations
- Proactively mitigate risks through early engagement
- Provide technical quality oversight for medical device pilot plants
- Support strategies for comprehensive maintenance programs
- Ensure reliable operation of equipment, utilities, and systems
- Monitor effectiveness of maintenance programs
- Recommend technical improvements for maintenance
- Oversee qualification of equipment and utilities to regulatory standards
- Ensure ongoing compliance throughout the operational lifecycle
- Establish monitoring strategies for standardized calibration programs
- Ensure data integrity through calibration programs
- Manage complex non-conformances in calibration
- Provide technical oversight for critical utilities (HVAC, water, air, steam)
- Ensure critical utilities meet quality and regulatory performance standards
Work Experience
- 10 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GMP
- FDA
- EMA
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 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
F. Hoffmann-La Roche AG
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Not a perfect match?
- ten23 health
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Full-time/Part-timeOn-siteExperiencedBasel - Roche
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Full-timeOn-siteExperiencedKaiseraugst - 1201 F. Hoffmann-La Roche AG
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Full-timeOn-siteSeniorBasel - Roche
Unit Lead Reliability Engineering - Engineering Science and Technology (ES&T)(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - Roche
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