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BA
Bavarian Nordic GmbH
14d ago

Senior Quality Assurance Specialist - GVP(m/w/x)

Martinsried
Full-timeRemoteSenior

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.

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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

Bachelor's degree

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

GCP

Languages

EnglishBusiness Fluent

GermanBasic

Benefits

Flexible Working

  • Inclusive and flexible workplace

Learning & Development

  • Personal and professional development
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Bavarian Nordic 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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