3626 BURGWEDEL BIOTECH GMBH
Associate Specialist External Laboratory QC(m/w/x)
Full-timeWith HomeofficeExperienced
Burgwedel
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363626 BURGWEDEL BIOTECH GMBH
Qualified Person - Human Vaccines(m/w/x)
Burgwedel
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
In this pivotal role, you will ensure the safety of human vaccines by managing batch certifications and GMP compliance while acting as a key expert during critical FDA and regulatory inspections.
Requirements
- Abgeschlossenes pharmazeutisches, naturwissenschaftliches oder technisches Studium
- Mehrjährige Berufserfahrung als Sachkundige Person
- Qualifikation als Sachkundige Person oder kurzfristige Qualifikationsmöglichkeit
- Kenntnisse über GMP, FDA, AMG, AMWHV und aseptische Fertigung
- Erfahrungen mit Shopflooraktivitäten und Audits
- Sehr gute Standardsoftwarekenntnisse
- Verantwortungsbewusstsein, Eigeninitiative, Teamfähigkeit und akkurate Arbeitsweise
- Hands-on-Mentalität, Durchsetzungsvermögen und verbindliches Auftreten
- Verhandlungssicheres Englisch und fließendes Deutsch
- Personalführungskompetenz wünschenswert
- Degree in pharmacy, sciences, engineering, or comparable qualification
- Several years of experience in pharmaceutical quality assurance
- Experience in vaccines, aseptic manufacturing, or biopharmaceutical processes
- Qualified Person qualification or ability to obtain it
- Knowledge of GMP, FDA, AMG, AMWHV and aseptic manufacturing
- Experience with audits, inspections, and shop floor activities
- Structured, independent working style and decision-making capability
- Strong communication, teamwork skills, and professional demeanor
- Business-fluent German and English skills
- Leadership experience is desirable but not mandatory
Tasks
- Certify and release vaccine batches and drug substances
- Ensure GMP-compliant manufacturing and testing processes
- Perform duties according to EU GMP Annex 16
- Assess deviations, OOS cases, and quality agreements
- Act as subject matter expert for quality topics
- Review and approve GMP-relevant documentation
- Lead or participate in quality management projects
- Collaborate with QA managers and cross-functional teams
- Prepare and support GMP and FDA inspections
Work Experience
approx. 4 - 6 years
Education
Master's degree
Languages
German – Business FluentEnglish – Business Fluent
Tools & Technologies
MS-OfficeDatenbanksysteme
Benefits
Purpose-Driven Work
- •Responsible key role
Flexible Working
- •Flexible working models
- •Part-time options
Other Benefits
- •Professional work environment
- •Strong quality culture
Informal Culture
- •Interdisciplinary and international teams
Competitive Pay
- •Attractive employment conditions
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 3626 BURGWEDEL BIOTECH 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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363626 BURGWEDEL BIOTECH GMBH
Qualified Person - Human Vaccines(m/w/x)
Burgwedel
Full-time, Part-timeWith Home OfficeSenior
Nejo AI Summary
In this pivotal role, you will ensure the safety of human vaccines by managing batch certifications and GMP compliance while acting as a key expert during critical FDA and regulatory inspections.
Requirements
- Abgeschlossenes pharmazeutisches, naturwissenschaftliches oder technisches Studium
- Mehrjährige Berufserfahrung als Sachkundige Person
- Qualifikation als Sachkundige Person oder kurzfristige Qualifikationsmöglichkeit
- Kenntnisse über GMP, FDA, AMG, AMWHV und aseptische Fertigung
- Erfahrungen mit Shopflooraktivitäten und Audits
- Sehr gute Standardsoftwarekenntnisse
- Verantwortungsbewusstsein, Eigeninitiative, Teamfähigkeit und akkurate Arbeitsweise
- Hands-on-Mentalität, Durchsetzungsvermögen und verbindliches Auftreten
- Verhandlungssicheres Englisch und fließendes Deutsch
- Personalführungskompetenz wünschenswert
- Degree in pharmacy, sciences, engineering, or comparable qualification
- Several years of experience in pharmaceutical quality assurance
- Experience in vaccines, aseptic manufacturing, or biopharmaceutical processes
- Qualified Person qualification or ability to obtain it
- Knowledge of GMP, FDA, AMG, AMWHV and aseptic manufacturing
- Experience with audits, inspections, and shop floor activities
- Structured, independent working style and decision-making capability
- Strong communication, teamwork skills, and professional demeanor
- Business-fluent German and English skills
- Leadership experience is desirable but not mandatory
Tasks
- Certify and release vaccine batches and drug substances
- Ensure GMP-compliant manufacturing and testing processes
- Perform duties according to EU GMP Annex 16
- Assess deviations, OOS cases, and quality agreements
- Act as subject matter expert for quality topics
- Review and approve GMP-relevant documentation
- Lead or participate in quality management projects
- Collaborate with QA managers and cross-functional teams
- Prepare and support GMP and FDA inspections
Work Experience
approx. 4 - 6 years
Education
Master's degree
Languages
German – Business FluentEnglish – Business Fluent
Tools & Technologies
MS-OfficeDatenbanksysteme
Benefits
Purpose-Driven Work
- •Responsible key role
Flexible Working
- •Flexible working models
- •Part-time options
Other Benefits
- •Professional work environment
- •Strong quality culture
Informal Culture
- •Interdisciplinary and international teams
Competitive Pay
- •Attractive employment conditions
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 3626 BURGWEDEL BIOTECH 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.
About the Company
3626 BURGWEDEL BIOTECH GMBH
Industry
Pharmaceuticals
Description
The company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
Not a perfect match?
- 3626 BURGWEDEL BIOTECH GMBH
Associate Specialist External Laboratory QC(m/w/x)
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