Qualified Person

  • Location

    Germany
  • Job Type

    Permanent
  • Functions

    Quality Assurance

Role – Qualified Person

Scienta are proud to be partnered with one of Germany’s leading innovators in ADC’s, who have recently put over a billion in funding to their German site – prompting the need for a new QP to join their teams!

Qualified Person (m/f/d) for clinical investigational medicinal products

  • All activities that fall under the role of a Qualified Person
  • 14 AMG for clinical investigational medicinal products, EU-GMP Guide Annex 16, Annex 13 and Clinical Trial Regulation (CTR) for clinical investigational medicinal products.
  • Decision on release or rejection of starting materials, packaging material, intermediate products, bulk goods and final packaged investigational medicinal products
  • preparation and approval of specifications
  • Preparation and approval of instructions (SOPs) and other regulations and documents relating to the release process of clinical investigational medicinal products
  • Review and approval of manufacturing and packaging documentation
  • Preparation, review and approval of documents for submission to authorities regarding the approval of clinical trials (IMPD, CMC part, QP declaration, Master Label Approval)
  • Review of pharmaceutical-technical complaints concerning clinical investigational medicinal products
  • Preparation of QP declarations for the import authorization of medicinal products according to 72 AMG
  • Assessment of deviations, OOS, OOE and OOT results, CAPA measures and change control requests as well as their review and approval
  • Determination of product life cycles based on stability data
  • Auditing of contract manufacturers, packers and contract laboratories

Professional and personal requirements

  • Scientific studies, preferably in pharmacy, as well as several years of practical experience in the development and testing of medicinal products with sound specialist knowledge of pharmaceutical analysis, expertise in accordance with 15 Abs.1 AMG
  • Very good English skills and intercultural competence due to the various international interfaces
  • organizational skills and leadership qualities for planning, organizing and controlling the deployment of employees
  • Profound experience in the interpretation of analytical stability data for determining product shelf life, several years of practical experience in the field of qualitative and quantitative analysis and other quality testing of medicinal products
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