Qualified Person

**QP ATMPs - Germany - Competitive Package**

BioTalent are currently supporting a leading Global Biopharmaceutical organization with this position supporting the Cell & Gene therapy storage and distribution facility. They are in search for a QP to focus on the release/certification of clinical investigational medicinal products.

**Responsibilities**:

- Approval decision for IMPs.
- Conducting audits.
- Review of manufacturing documents and validation documents.
- Supervision of customer projects with direct contact with authorities.
- Responsibility for the decision on the use of drug batches for clinical trials in accordance with AMG and EU Annex 13 and 16.

**Requirements**:

- Approval as a pharmacist and expertise according to - 15 AMG.
- QP according to German Medicines Act (- 14 AMG, QP according to Directive 2001/83/EU)
- Practical experience to pharmaceutical manufacturing.
- Fluent in German and English.

This is an excellent opportunity to get involved in a global leader that produces lifesaving products whilst working at the forefront of science with a strong culture of collaboration. It will give you an play a critical role in Cell & Gene activities on the facility.