Qualified Person

vor 1 Monat


Stuttgart, Deutschland BioTalent Vollzeit

CONTRACT ASSIGNMENT ONLY

6 month contract - potential to extend

Must be onsite in Stuttgart region

Competitive hourly rate available


  • Approval of medicinal products and investigational medicinal products as a qualified person in accordance with Section 14 AMG Paragraph 1
  • Release of bulk goods from external contract manufacturing companies for further processing
  • Ensuring compliance and implementation of requirements from the Medicines Act, AMWHV and EC GMP guidelines
  • Personal responsibility for the market release of medicines
  • Supporting the head of quality control in pharmaceutical law issues as an expert person. § 14 AMG paragraph 1
  • Ensuring the proper handling, documentation and processing of deviations, cause analyzes and change control processes
  • Contact person for complaints from authorities and participation in the investigation of drug complaints
  • Ensuring that approved medicinal products are manufactured and tested in accordance with the requirements laid down in the approval
  • Review and approval of change control procedures
  • Reviewing and approving PQRs (Periodical Quality Reviews of medicinal products) in coordination with the respective releasing pharmaceutical manufacturers
  • Ensuring proper drug production and maintenance of the quality management system in compliance with all relevant regulations
  • Organization and continuous improvement of the quality management system, taking business aspects into account
  • Contact person representing the surveillance authorities
  • Ensure compliance and monitoring of all GMP and legal quality requirements for all product categories
  • Checking pharmaceutical contracts: e.g. B. Quality agreements and responsibility delimitation contracts
  • Technical collaboration in the new and further development of drugs and formulations
  • Ensuring stability tests and monitoring product stability


Reach out to daniel.jeffery@biotalent.com for more information.


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