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Senior Quality Assurance Specialist - GVP(m/w/x)
Description
You will ensure data integrity and safety by leading pharmacovigilance audits and managing inspections, while driving the continuous improvement of the Quality Management System.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Work Experience
7 years
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
Tools & Technologies
Languages
English – Business Fluent
German – Basic
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)
The AI Job Search Engine
Description
You will ensure data integrity and safety by leading pharmacovigilance audits and managing inspections, while driving the continuous improvement of the Quality Management System.
Let AI find the perfect jobs for you!
Upload your CV and Nejo AI will find matching job offers for you.
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
Education
Work Experience
7 years
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
Tools & Technologies
Languages
English – Business Fluent
German – Basic
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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