about 1 year ago
Qualified Person needed
The company is focusing on delivering transformative innovations that bring unique and more efficient personalized care. They work at key intersections where innovations that sustain lives meet the clinicians, nurses, and pharmacists who make it happen. They are always looking to improve the outcomes for patients. Therefore, the reason for a Qualified Person needed right now.
The Qualified Person is responsible for the batch certification and approval. They ensure that each individual batch of a medicinal product has been manufactured and tested in accordance with applicable German legislation in accordance with the requirements of the Marketing Authorization and Good Manufacturing Practice (GMP).
- Evaluation of deviations in relation to the quality of the product
- Release of the batch documentation
- Review of product complaints in accordance with legal requirements Release of product-specific quality reports (APQR)
- Graduate pharmacist with approbation, doctorate
- 15 AMG/ Article 49 of Directive 2001/83/ EC
- 5 Years’ experience in the pharmaceutical industry
- 2 years’ experience in QP
- Experience in aseptic production
- Proven knowledge of the EC GMP Guidelines and their reputation, in particular, Annexes 1 and 16
- Assertive and strong personality
- Excellent communication skills
- Business fluent German and English
If interested please click on the apply now button!