Qualified Person - Lohr, Deutschland - BioTalent

BioTalent

Geprüftes Unternehmen

Lohr, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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.