Beschreibung
QC ConsultantLong-term (min. 8 years) QC experience for development projects, especially for late stage phase of new
active substances (NCE)
fundamental GMP understanding
Excellent knowledge on requirements (ICH, EMA, ANVISA) for analytical method validation,
specifications, stability testing, PPQ (changes of analytical methods and specification before and after
PPQ and its impact on the project)
Experience in:
Reference standard qualification
specification setting for MAA for starting materials and intermediates incl. justification of specification,
setting up fate and purge studies
analytical method transfer from development to production
Expertise in key methods: GC, HPLC, LC-MS, PSD (laser diffraction)
fluent English and German (written and spoken)
Experienced in providing technical leadership and trainings
Experienced in colaboration with Chinese CMOs
on site visit at Chinese CMO (if necessary)
Einsatzort: Darmstadt
Weitere Einsatzorte: 5 days/week, 100% onsite support
Gewünschter Beginn: 16.04.2018
Geplantes Ende: 30.11.2018
Anzahl Projekttage: 150 Tage
Benötigte Kenntnisse
Analytical transfer from dev. to QC +++ (excellent), > 6 yrs.
Collaboration with Chinese CMO 0 nice to have
GC, LC, LC-MS, Laser diffraction +++ (excellent), > 6 yrs.
ICH guidelines, GMP +++ (excellent), > 6 yrs.
min. 8 years experience in pharma +++ > 5 yrs.
Languages English +++ business fluent
German +++ business fluent
Maik Thieme
Real Life Sciences Goetheplatz 5-11, 60313 Frankfurt Am Main, Germany
T:
E: m.thieme(a)realstaffing.com
Sthree Germany is acting as an Employment Business in relation to this vacancy.