Qualified Person - Thayer, KS, United States - Emerald Enterprises

Emerald Enterprises
Emerald Enterprises
Verified Company
Thayer, KS, United States

4 weeks ago

James Miller

Posted by:

James Miller

beBee Recruiter
Freelance
Description

As a Qualified Person (QP) in Thayer, KS, you will ensure the compliant production, labeling, testing, and release of nephrological medicines.

You will also be responsible for the contract manufacturing of these medicines. As a Director (m/w/d), you will lead a small team of 4-5 experts. Together with your team, you will ensure the supply of high-quality medicines to our patients.


Your responsibilities:


  • Ensuring the production, testing, labeling, and release of medicines in accordance with legal regulations, particularly the Medicines Act (AMG), the Medicinal and Active Substance Manufacturing Regulation (AMWHV), and the EU-GMP guidelines
  • Responsible for contract manufacturing (GMP)
  • Responsible for the regulatory measures necessary for the qualification, coordination, and control of external suppliers of medicines, active substances, and other critical materials, as well as critical service providers (e.g. laboratories)
  • Ensuring the creation, review, or update of registration documents for medicines (part quality) in compliance with regulatory and legal requirements
  • Participation in the continuous improvement of the underlying quality assurance system, ensuring implementation in the area of responsibility
  • Managing an expert team both disciplinarily and professionally

Your profile:


  • Completed university degree in pharmacy or a related natural science field
  • Qualified Person (QP) according to § 15 AMG
  • Several years of practical experience in the pharmaceutical industry, preferably in production and/or quality control of
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