Beschreibung
* Conduct Gap analysis for technological requirements to establish analytical methods for the Quality Control of biological entities (gel electrophoresis, capillary electrophoresis, ELISA, protein interaction analysis)* Work operatively to close technological gaps, e.g. prepare for technical investments (DQ, IQ, OQ) in GMP environment
* Conduct Gap analysis for quality requirements to establish analytical methods for the Quality Control of biological entities
* Close gaps with respect to GMP to establish analytical methods for the Quality Control of biological entities via writing of e.g. quality standards and GMP standard procedures in alignment with Quality Assurance
* Fluent german and english
* CMC development expertise
* At least 5 yeard expirience in characterization of biological entities and cGMP knowledge
Schlagwörter:
english, cmc development, biological entities, cGMP knowledge, technological requirements, Quality Control, Qualitätsmanagement, Biologie, Pharma
Kontaktperson: Personalreferentin Frau Hatmane Berisha
FERCHAU Engineering GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt