Project Quality Lead Development Quality

Beschreibung

Freelance Project Quality Lead Development Quality

I am currently looking for a Freelancer for a well-known pharmaceutical company in Hesse, Germany.

See details below:

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. 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.

Start date: 15.06.2016
End date: 30.09.2017
Utilization per week: 3-5 days
On-site: 100%
Remote: 0%

Industry specific skills

Drug product Process Validation +++ > 5 yrs.
Languages

English +++ business fluent
German 0 nice to have

GMP in development and routine manufacturing +++ (excellent), > 6 yrs.
Product & Process development & Validation +++ (excellent), > 6 yrs.
Quality by design +++ (excellent), > 6 yrs.

If you are interested do not hesitate to contact me!

Kind regards

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