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QA for QC Expert(m/w/x)
Quality oversight for analytical method validation and equipment CQV for injectable treatments at a pharma/biotech partner. Proven QA experience in GMP-regulated drug product manufacturing or testing required. Annual bonus.
Requirements
- Master's degree in science (Biology, Microbiology, Pharmacy, or similar)
- Proven QA experience in GMP-regulated drug product manufacturing or testing
- Strong understanding of QC operations, analytical methods, data integrity principles
- Experience in microbiology (plus)
- Fluency in spoken and written English
- Independent and efficient team player
- Thrives in interdisciplinary collaboration
- High degree of flexibility in problem-solving
- Proactive approach to contributing ideas
- Strong willingness to take on responsibilities
Tasks
- Lead quality oversight for analytical method validation.
- Lead quality oversight for equipment CQV.
- Manage equipment lifecycle.
- Review and approve GMP documentation.
- Review and approve material specifications.
- Review and approve analytical records.
- Review and approve QC results.
- Review and approve CoA/TSE/BSE statements.
- Perform regular GMP walks.
- Provide on-floor oversight for sampling.
- Provide on-floor oversight for transport.
- Provide on-floor oversight for general QC operations.
- Manage material labels.
- Manage ERP material status (excluding Drug Product).
- Handle the release of materials.
- Administer MODA system.
- Oversee sampling plans.
- Oversee APS quality requirements.
- Manage Deviations within QC.
- Manage CAPAs within QC.
- Manage Change Controls within QC.
- Support laboratory investigations.
Work Experience
- 2 - 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Career Advancement
- Career development opportunity
Flexible Working
- Flexible working arrangements
Informal Culture
- Open culture
- Diverse workforce
Mentorship & Coaching
- Opportunity to learn from experienced employees
Learning & Development
- Learning and self-developing culture
- Training options
Not a perfect match?
- RocheFull-timeOn-siteSeniorKaiseraugst
- 1201 F. Hoffmann-La Roche AG
QC Investigator(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - Novartis Pharma Schweizerhalle AG
QC Analyst II(m/w/x)
Full-timeOn-siteExperiencedBasel - Lonza
Scientist Primary Packaging & Raw Materials QC(m/w/x)
Full-timeOn-siteExperiencedBasel - Lonza
Project Lead Phys-Chem QC(m/w/x)
Full-timeOn-siteSeniorBasel
QA for QC Expert(m/w/x)
Quality oversight for analytical method validation and equipment CQV for injectable treatments at a pharma/biotech partner. Proven QA experience in GMP-regulated drug product manufacturing or testing required. Annual bonus.
Requirements
- Master's degree in science (Biology, Microbiology, Pharmacy, or similar)
- Proven QA experience in GMP-regulated drug product manufacturing or testing
- Strong understanding of QC operations, analytical methods, data integrity principles
- Experience in microbiology (plus)
- Fluency in spoken and written English
- Independent and efficient team player
- Thrives in interdisciplinary collaboration
- High degree of flexibility in problem-solving
- Proactive approach to contributing ideas
- Strong willingness to take on responsibilities
Tasks
- Lead quality oversight for analytical method validation.
- Lead quality oversight for equipment CQV.
- Manage equipment lifecycle.
- Review and approve GMP documentation.
- Review and approve material specifications.
- Review and approve analytical records.
- Review and approve QC results.
- Review and approve CoA/TSE/BSE statements.
- Perform regular GMP walks.
- Provide on-floor oversight for sampling.
- Provide on-floor oversight for transport.
- Provide on-floor oversight for general QC operations.
- Manage material labels.
- Manage ERP material status (excluding Drug Product).
- Handle the release of materials.
- Administer MODA system.
- Oversee sampling plans.
- Oversee APS quality requirements.
- Manage Deviations within QC.
- Manage CAPAs within QC.
- Manage Change Controls within QC.
- Support laboratory investigations.
Work Experience
- 2 - 5 years
Education
- Master's degree
Languages
- English – Business Fluent
Benefits
Retirement Plans
- Competitive pension fund plan
Bonuses & Incentives
- Annual bonus
Career Advancement
- Career development opportunity
Flexible Working
- Flexible working arrangements
Informal Culture
- Open culture
- Diverse workforce
Mentorship & Coaching
- Opportunity to learn from experienced employees
Learning & Development
- Learning and self-developing culture
- Training options
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.
Not a perfect match?
- Roche
Head of QA for QC(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - 1201 F. Hoffmann-La Roche AG
QC Investigator(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - Novartis Pharma Schweizerhalle AG
QC Analyst II(m/w/x)
Full-timeOn-siteExperiencedBasel - Lonza
Scientist Primary Packaging & Raw Materials QC(m/w/x)
Full-timeOn-siteExperiencedBasel - Lonza
Project Lead Phys-Chem QC(m/w/x)
Full-timeOn-siteSeniorBasel