Are you looking to take your next step in your career in quality?
A well renowned pharmaceutical manufacturer in south Germany is looking for a Qualified Person.
This organization has recently invested half a billion dollars into expanding its bioprocessing plants. They are also working with some of the most exciting compounds on the market today. This could be the perfect move for you.
As a competent person in accordance with AMG§14 or AMG§15, you are responsible for the approval / certification of investigational medicinal products.
You have intensive customer contact with your customers - the who-is-who from the pharmaceutical industry - and support them in the implementation of their projects. The accompaniment or independent implementation of audits worldwide is another important part of your job. Just like working with start-ups, to whom we make our expertise available. Our goal is to train you in the area of quality assurance, to learn from your knowledge and to grow with you.
Your areas of responsibility are
- Certification of clinical investigational drugs
- Supervision of customer projects as well as advising customers on QP and regulatory issues
- Participation in customer audits and inspections by the authorities
- Direct contact with authorities
- Creation of QP declarations
- Creation and approval of SOPs
- Assistance in processing complaints and deviations
- Responsibility for the decision to use drug batches for clinical trials in accordance with AMG and EU Annex 13 and 16
- Review of manufacturing and validation documents
- Participation in new projects for supply chain management
What we are looking for
- Approval as a pharmacist with 2 years of experience in pharmaceutical quality control
- Qualification as a competent person according to § 15 (1) AMG
- Fluent written and spoken German and English
Are you interested. Apply now and discover more about this role.