Quality Sterility Assurance

Région
Wavre
Publication
jeudi 14 septembre 2017
Date limite
samedi 14 octobre 2017
Réf
71FE2XPE-BE
Contact
Julie Begine
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Quality Sterility Assurance Organisation description:

XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services.

We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product.

As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment.

Job description:

Drive and execute continuous improvement project or remediation plan related to sterility assurance, including change control management, SOP's review, …

Manage relationship with aseptic operations in the context of the tasks describe.

Identify potential quality and compliance risks and help to manage these risks through the existing quality systems.

Performs gap analysis, system effectiveness reviews and other management reviews, as required.

Guarantees the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method validation)

Ensures and supports the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring as required

Contributes to inter-MPU QA meetings to share knowledge and practices and to review sterility assurance issues as to foster continuous improvement and manage risks

Profile:
  • Relevant experience in sterility assurance
  • Previous experience in QA in the pharmaceutical industry
  • Experience in GxP
  • Able to work on the shop floor with a coaching and mentoring style to impact individual experiences
  • PhD or Master in Sciences (Microbiology, Engineering, Bio- engineering, , Pharmacy ……) or equivalent by experience
  • Significant GxP experience
  • SAP, Excel, Word
  • French & English
Offer:

What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra-legal advantages!

If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client.

XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713