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STADA Arzneimittel AG
16d ago

Qualified Person / QP(m/w/x)

Bad Vilbel
Full-timeWith Home Office

Description

As a Qualified Person in Finished Product Control, you will play a vital role in ensuring product quality and compliance. Daily tasks will involve approving products, addressing operational issues, and overseeing testing processes to meet legal and GMP standards.

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Requirements

  • •Degree in pharmacy with licensure or degree in natural sciences
  • •Qualification according to expert opinion under §15 AMG
  • •Good knowledge of legal frameworks such as cGMP, AMG, and AMWHV
  • •Skilled in pharmaceutical analytics
  • •Demonstrated initiative and assertiveness
  • •Effective and clear communication
  • •Proficiency in spoken and written English and German

Education

Bachelor's degree

Tasks

  • •Ensure compliance with legal regulations for each batch
  • •Approve or reject bulk and finished products
  • •Sign corresponding test protocols
  • •Approve specifications, sampling instructions, and testing instructions
  • •Monitor implementation of testing requirements
  • •Address daily operational issues
  • •Implement QS-relevant parts of CCPs/MOCs
  • •Handle deviations and test reports
  • •Organize departmental documentation per GMP guidelines
  • •Evaluate Product Quality Reviews (PQRs) and stability studies

Languages

English – Business Fluent

German – Business Fluent

Benefits

Flexible Working

  • •Flexible working hours
  • •Mobile working up to 2 days per week

Informal Culture

  • •Open corporate culture

Learning & Development

  • •Individual development opportunities

Public Transport Subsidies

  • •Job ticket for RMV region

Company Bike

  • •Job Bike

Additional Allowances

  • •Childcare allowance

Healthcare & Fitness

  • •Health-promoting offers

Other Benefits

  • •Group accident insurance

Retirement Plans

  • •Supplementary pension scheme

Free or Subsidized Food

  • •Subsidized cafeteria
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