Qualified person according to §14 AMG (Freelance) (m/w/d)
We are currently looking for a contract QP who is able to support in the following areas:
- Batch release of finished medicinal products according to GMP Annex 16
- Support in all quality-related issues
- Collaboration in OOS processes, change control, deviations and CAPA procedures as well as complaints
- Representation of GMP relevant aspects towards authorities and customers
- Evaluation of stability data
- Performance of employee trainings
- Fulfillment of the legal requirements for the qualification as a QP: License to practice as a pharmacist (AMG § 15,1.1) or the certificate of a completed university degree in pharmacy, chemistry, biology, human or veterinary medicine (AMG § 15,1.2) in conjunction with § 15,2 as well as at least two years of practical experience in the field of qualitative and quantitative analysis and other quality testing of drugs ( AMG § 15,1).
- Several years of professional experience in the pharmaceutical industry.
- Experience in the field of semi-solid dosage forms.
- Excellent knowledge of pharmaceutical regulations and GMP standards
- Fluent written and spoken German and very good knowledge of English