Qualified Person (m-f-d)

Rheinfelden OR Weil am Rhein

Position
The focus of this role is on the release/certification of investigational medicinal products. In addition to in-house training, you will be involved in specific customer projects.

* Release decision for clinical investigational medicinal products
* Support of customer projects
* Conducting audits
* Direct contact with authorities
* Creation of QP Declarations
* Approval of SOPs
* Processing of complaints
* Approval for commissioning contract laboratories
* Advising customers on QA issues
* Responsibility for the decision to use medicinal product batches for clinical trials in accordance with the German Medicines Act (AMG) and EU Annexes 13 and 16
* Review and approval of statements on deviations
* Root cause analysis of deviations
* Review of manufacturing documents and validation documents
* Conducting audits (international)

Qualifications
* Degree in pharmacy with 2 years of experience in pharmaceutical quality control
* License to work as a pharmacist and expertise according to Section 15 AMG
* Qualified person according to the German Medicines Act (§14 AMG, corresponds to "Qualified Person" according to Directive 2001/83/EU)
* At least two years of experience in the field of qualitative and quantitative analysis and other quality testing of medicinal products
* Practical relevance to pharmaceutical manufacturing
* Quality-conscious and systematic working methods as well as strong analytical skills in risk assessment
* High customer and service orientation
* Fluent German and English skills