CH12 Lonza AG
(Senior) QA Qualification Specialist(m/w/x)
Full-timeOn-siteExperienced
Visp
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Overseeing qualification of facilities, utilities, equipment, and systems for injectable treatments. Pharmaceutical industry experience, ideally Annex 1 regulated, required. Flexible working arrangements, learning from experienced employees.
Requirements
- University degree in natural science or engineering
- Significant pharmaceutical industry experience, ideally Annex 1 regulated
- Experience with Major Equipment Qualification is a plus
- Good understanding of applicable cGMP regulations
- Experience in quality assurance, MSAT, or pharmaceutical operations
- Good knowledge of engineering and manufacturing processes
- Ability to oversee project execution for non-compliance identification
- Good German and English language skills required
Tasks
- Oversee qualification of facilities, utilities, equipment, and systems
- Coordinate on-site qualification activities
- Review and approve qualification documents
- Ensure timely requalifications according to QMP
- Review and approve URS, GMP RA, and qualification plans and reports
- Manage incidents and deviations in qualification activities
- Handle pending qualification items
- Drive implementation of qualification strategy
- Make strong decisions as needed
- Ensure compliance with regulatory and in-house requirements
- Evaluate and approve technical change requests
- Assess change relevance to qualification
- Serve as contact for maintenance-specific questions
- Prepare and release maintenance/qualification reports
- Represent qualification topics during customer audits and inspections
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Career Advancement
- Career development opportunity
Flexible Working
- Flexible working arrangements
- Flexibility
Informal Culture
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentorship & Coaching
- Learning from experienced employees
Learning & Development
- Wide range of training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Other Benefits
- Other financial and non-financial benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health 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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Overseeing qualification of facilities, utilities, equipment, and systems for injectable treatments. Pharmaceutical industry experience, ideally Annex 1 regulated, required. Flexible working arrangements, learning from experienced employees.
Requirements
- University degree in natural science or engineering
- Significant pharmaceutical industry experience, ideally Annex 1 regulated
- Experience with Major Equipment Qualification is a plus
- Good understanding of applicable cGMP regulations
- Experience in quality assurance, MSAT, or pharmaceutical operations
- Good knowledge of engineering and manufacturing processes
- Ability to oversee project execution for non-compliance identification
- Good German and English language skills required
Tasks
- Oversee qualification of facilities, utilities, equipment, and systems
- Coordinate on-site qualification activities
- Review and approve qualification documents
- Ensure timely requalifications according to QMP
- Review and approve URS, GMP RA, and qualification plans and reports
- Manage incidents and deviations in qualification activities
- Handle pending qualification items
- Drive implementation of qualification strategy
- Make strong decisions as needed
- Ensure compliance with regulatory and in-house requirements
- Evaluate and approve technical change requests
- Assess change relevance to qualification
- Serve as contact for maintenance-specific questions
- Prepare and release maintenance/qualification reports
- Represent qualification topics during customer audits and inspections
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Career Advancement
- Career development opportunity
Flexible Working
- Flexible working arrangements
- Flexibility
Informal Culture
- Open culture
- Diverse workforce
- Minimal bureaucracy
Mentorship & Coaching
- Learning from experienced employees
Learning & Development
- Wide range of training options
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Other Benefits
- Other financial and non-financial benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
ten23 health
Industry
Pharmaceuticals
Description
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
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