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.