QA GMP Compliance - 10383

19-1-2020 wavre
description de la société

Our client is a global vaccine research, development and production company, that employs over 11,200 people worldwide, of which 7,500 in its three Belgian sites: Rixensart, Wavre and Gembloux.

description de la fonction

If you are a QA GMP Compliance who's looking for a new challenge, don't hesitate to contact me !

megane.libert@cx.ausy.be / +32(0)497/61.85.75

Mégane Libert

Provide support/or and oversight for QA activities related to the “in place/in use” aspect of one or more Quality systems (e.g. deviation treatment) within a Manufacturing Performance Unit.

Tasks :

  • Ensure support is provided to develop process documents that are in alignment with regulatory expectations and internal global policies and standards
  • Ensure state-of-the-art and best industry practices are reflected in our development
  • Manage QA activities related to one or more Quality Systems
  • Support the development of transversal GxP Process :
  1. SOPs on SOPs
  2. Training Management
  3. Archive Management
  4. Documentation Management
  5. Changement Management
  6. Deviation/CAPA Management
  7. Management review
  • Manage relationship with operations
  • Identify potential quality and compliance risks and help to manage these risks through the existing quality systems

vos atouts

  • Relevant experience
  • Previous experience in QA in a pharmaceutical industry
  • Experience in GxP (Aseptic, validation, cGxP, GMP)
  • PhD or Master in Sciences linked to Biotechnology/Vaccines development (Engineering, Bio- engineering, chemistry, ……) or equivalent by experience
  • Fluent in French
  • Good knowledge in English
  • Hands-on approach (able to work on the shop floor with a coaching and mentoring style to impact individual experiences)
  • Strong communication skills (able to communicate with different levels within MPU)
  • Influencing skills
  • Flexible mindset
  • Knowledge sharing
  • High negotiation skills
  • Achievement oriented

qu'offrons-nous?

A three months mission (with possibility of extension) as consultant at our client with a possibility of a permanent contract at Ausy.

A rate is freelance is also possible !

We offer an attractive salary with extra-legal advantages : 

  • Group insurance
  • Hospitalisation insurance
  • Meal vouchers of 7 euros gross per working day
  • Reimbursement km or company car 
  • Monthly allowance (50 euros net per month)
  • A 13th month
  • Training
  • Etc

sommaire
fonction
spécialiste en qualité et environnement (m/f)
type de job
temps plein, freelance
type contrat
missions à long terme
référence
CXRSP-87789
informations de contact
Libert Mégane
megane.libert@cx.ausy.be 02 474 60 16
02 474 60 16