ten23 health
QA for QC Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahren
Basel
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F.F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- GMP
- FDA
- EMA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens F. Hoffmann-La Roche AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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- 1201 F. Hoffmann-La Roche AG
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Validation Expert(m/w/x)
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Vollzeitnur vor OrtSeniorKaiseraugst
F.F. Hoffmann-La Roche AG
Quality Engineering Expert(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 10 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- GMP
- FDA
- EMA
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens F. Hoffmann-La Roche AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
F. Hoffmann-La Roche AG
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein führender Anbieter von pharmazeutischen Wirkstoffen und setzt sich für die Gesundheitsversorgung weltweit ein.
Noch nicht perfekt?
- ten23 health
QA for QC Expert(m/w/x)
Vollzeit/Teilzeitnur vor OrtBerufserfahrenBasel - 1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Vollzeitnur vor OrtSeniorBasel - Roche
Validation Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenKaiseraugst - Roche
Asset Excellence Lead AFL(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst - Roche
Unit Lead Reliability Engineering - Engineering Science and Technology (ES&T)(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst