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Senior Quality Assurance Specialist - GVP(m/w/x)
Leading pharmacovigilance audits and regulatory inspections for life-saving vaccine development. 7 years pharma/biotech and 5 years QA experience, with pharmacovigilance audit experience required. Flexible work options.
Requirements
- Determination to make things happen
- University degree in natural sciences or comparable qualification
- 7 years pharmaceutical or biotech experience
- 5 years quality assurance experience
- Experience conducting pharmacovigilance audits
- Knowledge of GCP (beneficial)
- Experience preparing and hosting regulatory inspections
- Knowledge of applied risk management
- Experience in managing projects
- Strong analytical, problem-solving and decision-making skills
- Fluency in English
- Knowledge of German (beneficial)
- Initiative and ownership
- Proactive and solution-oriented mindset
- Ability to work independently
- Strong communication skills
- Ability to maintain effective relationships
Tasks
- Support corporate pharmacovigilance audit programs
- Oversee subcontracted audit activities
- Lead internal and external pharmacovigilance audits
- Prepare for and host regulatory inspections
- Manage audits conducted by business partners
- Support quality oversight for pharmacovigilance
- Track change controls and investigations to closure
- Manage deviations and CAPA processes
- Develop and improve the Quality Management System
Work Experience
- 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GCP
Benefits
Flexible Working
- Inclusive and flexible workplace
Learning & Development
- Personal and professional development
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Senior Quality Assurance Specialist - GVP(m/w/x)
Leading pharmacovigilance audits and regulatory inspections for life-saving vaccine development. 7 years pharma/biotech and 5 years QA experience, with pharmacovigilance audit experience required. Flexible work options.
Requirements
- Determination to make things happen
- University degree in natural sciences or comparable qualification
- 7 years pharmaceutical or biotech experience
- 5 years quality assurance experience
- Experience conducting pharmacovigilance audits
- Knowledge of GCP (beneficial)
- Experience preparing and hosting regulatory inspections
- Knowledge of applied risk management
- Experience in managing projects
- Strong analytical, problem-solving and decision-making skills
- Fluency in English
- Knowledge of German (beneficial)
- Initiative and ownership
- Proactive and solution-oriented mindset
- Ability to work independently
- Strong communication skills
- Ability to maintain effective relationships
Tasks
- Support corporate pharmacovigilance audit programs
- Oversee subcontracted audit activities
- Lead internal and external pharmacovigilance audits
- Prepare for and host regulatory inspections
- Manage audits conducted by business partners
- Support quality oversight for pharmacovigilance
- Track change controls and investigations to closure
- Manage deviations and CAPA processes
- Develop and improve the Quality Management System
Work Experience
- 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Basic
Tools & Technologies
- GCP
Benefits
Flexible Working
- Inclusive and flexible workplace
Learning & Development
- Personal and professional development
About the Company
Bavarian Nordic GmbH
Industry
Pharmaceuticals
Description
The company is a global leader in developing life-saving vaccines with over 30 years of experience.
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