Associate Director, Qualified Person

Associate Director, Qualified Person

PAREXEL

Berlin, Germany

Job Purpose

As required by the German Drug Law (AMG), German Regulation “Arzneimittel- und Wirkstoffherstellungsverordnung (AMWHV)”, the Clinical Trial Directive 2001/20/EC and Annex 13 to the European GMP Guide, all Investigational Medicinal Products (IMPs) must be certified by a Qualified Person (QP) (German terminology according to AMG: “Sachkundige Person”) prior to release for use in a Clinical Trial and according to EU GMP Guideline published ICH Q10 (Pharmaceutical Quality System) and EU GDP Guideline.

The legal duties of the qualified person are to ensure that

  • Medicinal Products manufactured within the European Union have been manufactured and checked within the boundaries of national law and the requirements of the Marketing Authorization (MA) or Clinical Trial Application for IMP;
  • Product imported form 3rd countries were manufactured and tested as required by the applicable regulation;
  • Certify in a register or equivalent document, as operations are carried out and before any release, that each production batch was manufactured and tested as required by the applicable regulation;
  • These responsibilities of a Qualified Person may be delegated, but only to other Qualified Person(s);
  • QP release of Investigational Medicinal Products (IMP) as per Clinical Trial Regulations, in accordance with agreed protocols, the principles of International Conference on Harmonization, Good Clinical Practice and Good Manufacturing Practice;
  • Provide guidance on technical and regulatory requirements for the conduct of clinical trial and advice on GxP issues;
  • Ensuring correct procedures are followed and the process for assembly and supply of study medication (investigational medicinal products) for use in patients in clinical trial studies is controlled;
  • Ensuring Quality Control procedures are followed;
  • Assist with audits (internal/external) including supplier qualification audits (e.g. supplier providing starting materials).

Qualifications

Skills

  • Good communication skills;
  • Strong organisational skills;
  • Good attention to detail;
  • Adaptability.

Language Skills

  • German proficiency (written and oral);
  • English proficiency (written and oral).

Knowledge and Experience

  • Substantial post qualification experience within the Pharmaceutical Industry (Pharmacy, Regulatory Authority, Pharmaceutical Manufacturer);
  • Additionally, acquired practical experience is required over a period of at least two years, in one or more companies authorized to manufacture medicinal products in the EU, covering qualitative analysis of medicinal products, quantitative analysis of active substances and testing and checking the quality of medicinal products;
  • Experience with Clinical Trial Supplies (Manufacture and Packaging) as well as broad knowledge of pharmaceutical development and clinical trial process;
  • Experience with EU QP certification and release of IMP;
  • Experience with certification and release of IMP;
  • Experience with Import & Export of pharmaceutical products;
  • GMP/GCP auditing experience;
  • Regulatory Inspection experience.

Education

  • Fulfilment of qualification as per §15 AMG;
  • PhD degree in a science, technology or industry related discipline, preferred;
  • Member of a recognized regulatory body e. g. Chamber of Pharmacist, (such as German Authority “Landesamt für Umwelt, Gesundheit und Verbraucherschutz – Land Brandenburg).

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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