CSL Behring
Senior Scientific Expert Quality Compliance(m/w/x)
Part-timeOn-siteSenior
Bern
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CSCSL Behring
Senior Scientific Expert QA Batch Release Support(m/w/x)
Bern
Part-timeOn-siteSenior
Nejo AI Summary
Ensuring cGMP compliance for biotherapeutics via lot release documentation review and deviation investigation at a global biopharma leader. 3+ years' GMP experience in pharmaceutical/biotech or regulated industry required. Critical quality assurance function for life-saving therapies.
Requirements
- University degree in relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
- 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
- Knowledge of current Good Manufacturing Practices (cGMP) principles
- Knowledge of FDA and EMA requirements
Tasks
- Maintain the Quality Assurance System for compliance with company and cGMP standards.
- Maintain the audit program.
- Review functional and release documentation.
- Investigate deviations relevant to your area of responsibility.
- Review lot release documentation.
- Facilitate compliant release processes for the corresponding market.
- Respond to questions from authorities (e.g., Swissmedic, FDA) to ensure timely product release.
- Ensure SOPs are current and align with corporate and regulatory requirements.
- Execute training and awareness related to GMP standards.
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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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CSCSL Behring
Senior Scientific Expert QA Batch Release Support(m/w/x)
Bern
Part-timeOn-siteSenior
Nejo AI Summary
Ensuring cGMP compliance for biotherapeutics via lot release documentation review and deviation investigation at a global biopharma leader. 3+ years' GMP experience in pharmaceutical/biotech or regulated industry required. Critical quality assurance function for life-saving therapies.
Requirements
- University degree in relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
- 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
- Knowledge of current Good Manufacturing Practices (cGMP) principles
- Knowledge of FDA and EMA requirements
Tasks
- Maintain the Quality Assurance System for compliance with company and cGMP standards.
- Maintain the audit program.
- Review functional and release documentation.
- Investigate deviations relevant to your area of responsibility.
- Review lot release documentation.
- Facilitate compliant release processes for the corresponding market.
- Respond to questions from authorities (e.g., Swissmedic, FDA) to ensure timely product release.
- Ensure SOPs are current and align with corporate and regulatory requirements.
- Execute training and awareness related to GMP standards.
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CSL Behring 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
CSL Behring
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein globaler Marktführer in der Biotherapeutik, der innovative Therapien für Patienten mit immunologischen, hämatologischen, kardiovaskulären und anderen Erkrankungen entwickelt.
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