CH12 Lonza AG
Deviation Specialist(m/w/x)
Full-timeOn-siteNot specified
Visp
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Managing deviations in logistics and hygiene for biopharmaceutical production, including GMP documentation and cleaning plans. 5 years in GMP biopharmaceutical manufacturing required. Relocation assistance provided.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- TrackWise
- LIMS
Benefits
Bonuses & Incentives
- Compensation programs recognizing high performance
Corporate Discounts
- Numerous lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza 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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Managing deviations in logistics and hygiene for biopharmaceutical production, including GMP documentation and cleaning plans. 5 years in GMP biopharmaceutical manufacturing required. Relocation assistance provided.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- TrackWise
- LIMS
Benefits
Bonuses & Incentives
- Compensation programs recognizing high performance
Corporate Discounts
- Numerous lifestyle benefits
- Leisure benefits
Family Support
- Family benefits
Other Benefits
- Relocation assistance
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CH12 Lonza 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
CH12 Lonza AG
Industry
Pharmaceuticals
Description
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
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