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Job

Qualified Person (QP)

  • Location

    Stuttgart, Germany

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Luisa Namadila

  • Contact email:

    l.namadila@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    2 months ago

  • Expiry date:

    2019-12-29

** GERMAN SPEAKING QP**

Hamlyn Williams are working with a globally successful pharma in the South-West of Germany, who are looking for a QP on a perm basis. Must be fluent in German and English.

In this capacity, you are responsible for ensuring the quality of the medicines manufactured in the area of ​​responsibility and their release for use in clinical trials.

Key responsibilities include but is not limited to:

  • Certification of drug batches as a knowledgeable person
  • Participation in the development, production, testing and approval of medicinal products as a qualified person in accordance with §§ 13, 15 AMG
  • Information and advice to employees, physicians and other healthcare stakeholders through product risk assessment of drugs
  • Keeping a continuous register of all released batches in accordance with § 19 AMG in conjunction with § 17 AMWHV
  • Evaluation and approval of deviations and complaints
  • Auditing of manufacturing and testing facilities
  • Participation in the supervision of customer audits and official inspections

If you are a QP looking for a new opportunity, don't hesitate to get in touch!