Qualified Person / QP (f/m/d) in Finished Product Control

STADA Arzneimittel AG

Job Description

"Caring for People's Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Qualified Person / QP (f/m/d)
Bad Vilbel | Germany (DE) | Full-time | Permanent | Quality | Management / Executives


As a Qualified Person (m/f/d) in Finished Product Control, you take on the critical responsibility as a Qualified Person according to §14 AMG and as the Head of Quality Control according to §14 AMWHV for products not manufactured and packaged at the Bad Vilbel site.

  • You ensure that each batch is manufactured and tested in accordance with legal regulations
  • You approve or reject bulk and finished products and sign the corresponding test protocols
  • You approve specifications, sampling instructions, and testing instructions and ensure compliance with them
  • You determine the required scope of testing and monitor implementation, considering legal frameworks, GMP guidelines, and cost-effectiveness
  • You address issues arising from daily operations
  • You ensure the implementation of QS-relevant parts of CCPs/MOCs
  • You handle deviations and test reports as well as OOS-specific issues
  • You organize departmental documentation in accordance with GMP guidelines
  • You evaluate PQRs (Product Quality Reviews) and stability studies

  • You have completed a degree in pharmacy with licensure or a degree in natural sciences
  • You possess the qualification according to the expert opinion under §15 AMG
  • You have good knowledge of legal frameworks such as cGMP, AMG, and AMWHV
  • You are skilled in the field of pharmaceutical analytics
  • You demonstrate initiative and have assertiveness
  • You communicate effectively and clearly
  • You are proficient in both spoken and written English and German
  • Please submit your CV in English

  • An open corporate culture with fast decision-making processes and a lot of potential for your personal development
  • Individual development and training opportunities
  • Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
  • Job ticket for the RMV region and Job Bike
  • Childcare allowance
  • Health-promoting offers such as Wellpass or the STADA Gym (free of charge)
  • Numerous additional benefits such as group accident insurance or supplementary pension scheme
  • Subsidized cafeteria
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