CH12 Lonza AG
GMP Ops Support(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Visp
CH
CH12 Lonza AG6 Tage
Deviation & Capa Manager(m/w/x)
Vollzeit
Senior
Keine Angabe
3930 Visp
Nejo KI-Zusammenfassung
In this role, you will oversee the management of deviations and CAPA processes, ensuring compliance with GMP standards while driving continuous improvement in logistics and hygiene. Your day-to-day responsibilities will involve collaborating with various teams, conducting inspections, and optimizing quality systems.
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Anforderungen
- •Bachelor’s or Master’s degree in Logistics Engineering, Engineering, Material Management, Hygiene, or related field
- •Minimum of 5 years of experience in GMP-regulated biopharmaceutical or manufacturing environment
- •Strong knowledge of deviation management and CAPA processes
- •Experience with Quality Management Systems (e.g., TrackWise, LIMS, etc.) preferred
- •High level of technical understanding and ability to interpret complex processes and systems
- •Ability to work independently and manage responsibilities with minimal reliance on subject matter experts
- •Strong analytical and problem-solving skills
- •Fluency in German or English; bilingual proficiency is a plus
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
5 Jahre
Deine Aufgaben
- •Manage and evaluate deviations in logistics and hygiene areas for MC1 and MC2
- •Prepare, review, and maintain GMP documentation, including Deviation Reports, CAPAs, SOPs, and Risk Assessments
- •Develop, review, and implement process-related procedures such as Standard Operating Procedures and risk analyses
- •Prepare, update, and monitor cleaning plans in logistics and hygiene areas
- •Manage interfaces between Logistics, Clean Utilities, Industrial Hygiene, QA, QC Monitoring, Facilities, and Production
- •Ensure correct implementation, documentation, and approval of all GMP-related technical requirements
- •Support the preparation and review of GMP documentation and Change Requests for MC1 and MC2
- •Provide expert advice for cross-functional investigations related to logistics and hygiene processes
- •Conduct regular on-site inspections to identify potential risks and improvement opportunities
- •Execute CAPA actions and ensure timely follow-up and closure within the Quality Management System
- •Collaborate with cross-functional teams to address and resolve quality issues
- •Identify trends and propose recommendations for process optimization and quality enhancement
- •Support internal and external audits and regulatory inspections
Tools & Technologien
TrackWiseLIMS
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
Deine Vorteile
Boni & Prämien
- •Compensation programs recognizing high performance
Mitarbeiterrabatte
- •Numerous lifestyle benefits
- •Leisure benefits
Familienfreundlichkeit
- •Family benefits
Sonstige Vorteile
- •Relocation assistance
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CH12 Lonza 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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