Beschreibung
Project Quality Lead Development QualityYou will be the primary contact for quality issues in projects/products as member of product development teams.
You will provide global quality oversight for projects/products in scope by ensuring application of GMP requirements.
You support the preparation and ensure the execution of Quality activities integrated in CMC development plans, e.g. elements of QbD, GATE.
You prepare and communicate lessons learnt to MSQ and development network and ensure risk assessments are performed at appropriate stages of development and for decision making on issues arising.
You will support the timely preparation and completion of GMP documentation, operational sites in preparation of PAIs, quality management of CMOs used in development.
In your role you furthermore support and involve QPs in timely manner providing information on quality issues/topics needed for QP release.
Skills:
Drug product Process Validation - 5 years minimum
GMP in development and routine manufacturing - 5 years minimum
Product & Process development & Validation - 5 years minimum
Quality by design - 5 years minimum
Risk assessment - 5 years minimum
Languages:
English - business fluent
German - nice to have
If you are interested do not hesitate to contact me!
Marcel Otto Recruitment Consultant Pharma / Medical Devices / Contract Division
Real Life Sciences
Ein Geschäftszweig der SThree GmbH Goetheplatz 5-7, 60313, Frankfurt
T:
E:
Global Village:
www.realstaffing.com
Mehr Informationen über Real Staffing erhalten Sie unter www.realstaffing.com/de