Roche Diagnostics GmbH
QA Manager Gene Therapy Quality /Sachkundige Person ATMP(m/w/x)
Full-timeOn-siteSenior
Mannheim
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AGAGC Biologics GmbH
Scientist im Bereich Quality Assurance Operations(m/w/x)
Heidelberg
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring GMP compliance for active substance manufacturing and QC testing. Approx. 8 years QA experience in biotech required. Friendly, collaborative culture, personal initiative recognition.
Requirements
- Scientific degree (e.g., Biotechnology, Pharmacy, Chemistry, or similar)
- Approx. 8 years QA experience in pharmaceutical/biotech company
- IT experience with TrackWise, MS Office, and databases desirable
- Teamwork, responsibility, and quality awareness
- Very good German and English skills
- Valid work permit
Tasks
- Ensure GMP compliance during manufacturing, QC testing, and release of active substances
- Design and implement GMP-compliant quality management systems
- Adapt systems to new laws and guidelines
- Conduct management reviews and regular KPI reporting
- Manage documentation, including harmonizing QS systems across AGC Biologics sites
- Qualify suppliers, including audits and negotiating quality agreements
- Support customer audits and regulatory inspections
- Provide QA support for qualifications and validations
- Review batch records and prepare batch release
- Process deviations, OOS results, and change control procedures
- Follow up on CAPA actions
- Contribute to all QA activities in a pharmaceutical operation
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
Tools & Technologies
- TrackWise
- MS Office
Benefits
Competitive Pay
- Highly competitive compensation package
Informal Culture
- Friendly, collaborative culture
Other Benefits
- Personal initiative recognition
Career Advancement
- Professional achievement recognition
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AGC Biologics GmbH 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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AGAGC Biologics GmbH
Scientist im Bereich Quality Assurance Operations(m/w/x)
Heidelberg
Full-timeOn-siteSenior
Nejo AI Summary
Ensuring GMP compliance for active substance manufacturing and QC testing. Approx. 8 years QA experience in biotech required. Friendly, collaborative culture, personal initiative recognition.
Requirements
- Scientific degree (e.g., Biotechnology, Pharmacy, Chemistry, or similar)
- Approx. 8 years QA experience in pharmaceutical/biotech company
- IT experience with TrackWise, MS Office, and databases desirable
- Teamwork, responsibility, and quality awareness
- Very good German and English skills
- Valid work permit
Tasks
- Ensure GMP compliance during manufacturing, QC testing, and release of active substances
- Design and implement GMP-compliant quality management systems
- Adapt systems to new laws and guidelines
- Conduct management reviews and regular KPI reporting
- Manage documentation, including harmonizing QS systems across AGC Biologics sites
- Qualify suppliers, including audits and negotiating quality agreements
- Support customer audits and regulatory inspections
- Provide QA support for qualifications and validations
- Review batch records and prepare batch release
- Process deviations, OOS results, and change control procedures
- Follow up on CAPA actions
- Contribute to all QA activities in a pharmaceutical operation
Work Experience
- 8 years
Education
- Bachelor's degree
Languages
- German – Native
- English – Business Fluent
Tools & Technologies
- TrackWise
- MS Office
Benefits
Competitive Pay
- Highly competitive compensation package
Informal Culture
- Friendly, collaborative culture
Other Benefits
- Personal initiative recognition
Career Advancement
- Professional achievement recognition
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of AGC Biologics GmbH 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
AGC Biologics GmbH
Industry
Pharmaceuticals
Description
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) committed to delivering high standards of service.
Not a perfect match?
- Roche Diagnostics GmbH
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