Bavarian Nordic GmbH
Quality Assurance Specialist for Quality Control(m/w/x)
Full-timeOn-siteExperienced
Martinsried
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Maintaining training, document, and change control systems for pharmaceutical quality assurance in women's health and biosimilars. Master's degree and 1-3 years pharmaceutical QA experience in GDP/GMP environment required. Structured quality assurance processes.
Requirements
- Master Degree in Pharmacy, Chemistry, (Micro)Biology, Chemical Engineering, or equivalent
- 1-3 years pharmaceutical industry experience with QA in GDP/GMP environment
- GDP (Good Distribution Practice) knowledge and GMP understanding
- Fluent German and English (oral and written)
- High responsibility, accurate attention to detail, teamwork skills
- Strong communication skills, willingness to learn and develop
- Organizational skills
- Authenticity, empathy, curiosity, courage
- Ability to satisfy travel and credentialing requirements, including vaccination
Tasks
- Maintain the training management system
- Maintain the document management system
- Handle the change control system
- Prepare Annual Product Quality Reviews (APQRs)
- Support the management of the quality management system
- Support the development of the quality management system
- Support the oversight of the quality management system
- Manage the training system
- Prepare APQRs
- Review APQRs
- Support self-inspections
- Support follow-up activities for self-inspections
- Handle GDP-related topics with stakeholders
- Evaluate temperature excursions
- Support annual Transport Lane Risk Assessments
- Qualify suppliers for external service providers
- Oversee quality for external service providers
- Prepare quality agreements for third-party logistics (3PL)
- Revise quality agreements for third-party logistics (3PL)
- Prepare for global audits
- Participate in global audits
- Prepare for Health Authority inspections
- Participate in Health Authority inspections
Work Experience
- 1 - 3 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Organon 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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Maintaining training, document, and change control systems for pharmaceutical quality assurance in women's health and biosimilars. Master's degree and 1-3 years pharmaceutical QA experience in GDP/GMP environment required. Structured quality assurance processes.
Requirements
- Master Degree in Pharmacy, Chemistry, (Micro)Biology, Chemical Engineering, or equivalent
- 1-3 years pharmaceutical industry experience with QA in GDP/GMP environment
- GDP (Good Distribution Practice) knowledge and GMP understanding
- Fluent German and English (oral and written)
- High responsibility, accurate attention to detail, teamwork skills
- Strong communication skills, willingness to learn and develop
- Organizational skills
- Authenticity, empathy, curiosity, courage
- Ability to satisfy travel and credentialing requirements, including vaccination
Tasks
- Maintain the training management system
- Maintain the document management system
- Handle the change control system
- Prepare Annual Product Quality Reviews (APQRs)
- Support the management of the quality management system
- Support the development of the quality management system
- Support the oversight of the quality management system
- Manage the training system
- Prepare APQRs
- Review APQRs
- Support self-inspections
- Support follow-up activities for self-inspections
- Handle GDP-related topics with stakeholders
- Evaluate temperature excursions
- Support annual Transport Lane Risk Assessments
- Qualify suppliers for external service providers
- Oversee quality for external service providers
- Prepare quality agreements for third-party logistics (3PL)
- Revise quality agreements for third-party logistics (3PL)
- Prepare for global audits
- Participate in global audits
- Prepare for Health Authority inspections
- Participate in Health Authority inspections
Work Experience
- 1 - 3 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Organon 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
Organon
Industry
Healthcare
Description
The company delivers health solutions focused on women's health and expanding access to biosimilars.
Not a perfect match?
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