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DASGIP Information and Process Technology GmbH
29d ago

BP Regulatory Affairs Manager(m/w/x)

Jülich
Full-timeWith Home OfficeExperienced

Description

In this role, you will engage in a variety of tasks, including creating training materials and collaborating with teams and customers. Your focus will be on ensuring compliance with GMP guidelines and supporting quality initiatives across the organization.

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Requirements

  • •Degree in natural science, biotechnology, or comparable
  • •Solid quality background with core GxP systems
  • •Professional experience in quality or regulatory in pharma manufacturing
  • •Professional experience with quality tools in pharmaceutical industry
  • •Excellent communication skills in German and English
  • •Accurate and detail-oriented mindset
  • •Highly skilled in Microsoft Office applications
  • •Passionated and motivating attitude

Education

Bachelor's degree

Work Experience

approx. 1 - 4 years

Tasks

  • •Author and maintain internal guidance and training documentation
  • •Collaborate with global functions, suppliers, and customers to share expertise
  • •Review documents for alignment with GMP customer expectations
  • •Provide targeted training sessions and participate in global presentations
  • •Work closely with the Quality team to align on quality systems
  • •Support colleagues in implementing requirements and translating them into solutions

Tools & Technologies

GxP systemsComputer software validation (CSV)Equipment qualification (IQ/OQ)Process Validation

Languages

German – Business Fluent

English – Business Fluent

Benefits

More Vacation Days

  • •Thirty vacation days per year
  • •Company-regulated special leave days

Flexible Working

  • •Flexible flextime framework
  • •Working time account
  • •Remote work across Germany

Retirement Plans

  • •Employer-funded retirement plans

Company Bike

  • •Job bike

Public Transport Subsidies

  • •Public transport subsidies

Corporate Discounts

  • •Corporate benefits

Learning & Development

  • •Freely selectable training sessions
  • •Participation in conferences
  • •Access to learning platforms

Informal Culture

  • •Diverse and open-minded work environment
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of DASGIP Information and Process Technology 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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