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