QC Consultant R-Praziquantel

Darmstadt  ‐ Vor Ort
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Beschreibung

QC Consultant

Long-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.
Start
04/2018
Von
Real Staffing
Eingestellt
28.03.2018
Projekt-ID:
1528735
Vertragsart
Freiberuflich
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