Project Quality Leader (m/f)

REFERENZNUMMER:

305184/1

IHRE AUFGABEN:

-You 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
-Support the preparation and ensure the execution of Quality activities integrated in CMC development plans, e.g. elements of QbD, GATE and 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
-Also 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

IHRE QUALIFIKATIONEN:

-Fluent English language skills
-Experience in Drug product Process Validation
-Profund experience with GMP and Quality by design

WEITERE QUALIFIKATIONEN:

Project manager, Quality manager