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Qualified Person

Qualified Person

BioTalentBavaria, Germany, Germany
Vor 26 Tagen
Stellenbeschreibung

Qualified Person – Bavaria, Germany

BioTalent is working with a leading pharmaceutical organisation to support the search for a Qualified Person (QP) with strong experience in GMP, batch certification, and pharmaceutical quality systems.

This role will offer you

  • A pivotal QP position within a global organisation where you will work closely with the Site Quality Director.
  • The chance to collaborate across departments including QA, production, and regulatory affairs
  • The opportunity to shape and enhance quality and compliance processes

You will be responsible for

  • Certifying or rejecting product batches in accordance with AMG and GMP guidelines
  • Ensuring documentation and processes meet regulatory standards
  • Leading investigations into quality issues and implementing effective CAPAs
  • Supporting audits, inspections, and continuous improvement projects
  • Reviewing complaints, PQRs, and SOPs, and contributing to training and change control initiatives
  • Key Requirements :

  • Degree in Pharmacy or a relevant scientific field
  • Qualified Person status under §14 / 15 AMG
  • In-depth understanding of GMP and pharmaceutical regulations
  • Experience in manufacturing, quality documentation, and compliance
  • Please apply / email your resume with your availability to Duncan.johnston@biotalent.com to have a confidential discussion about this opportunity.

    BioTalent Ltd are acting as an employment agency in relation to this opportunity.

    Jobalert für diese Suche erstellen

    Qualified Person • Bavaria, Germany, Germany