QA Specialist

7 jours restants

Région
Wavre
Publication
mardi 4 juillet 2017
Date limite
vendredi 4 août 2017
Réf
6F0C2XPE-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: QA Specialist 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. The main aim of this mission is to ensure the compliance of data identified to be included in the PAS. Therefore, the mission as QA Consultant is to perform thorough data check of GMP documents and remediated any gap according to Quality System. You will provide to owners package for inspection readiness purpose.

Job description:

You ensure QA oversight in validation and production activities (IQOQ / PQ / PV, Batch records…) by performing thorough data check of GMP documents regarding the GMP requirements and the procedures. You ensure that quality issues or potential compliance risks are captured, followed up and treated through deviation and CAPA Quality Systems. You prepare inspection readiness package to give overview on specific topics, deviations, changes… You support the production, QA and technical service teams in the implementation of CAPA Globalization and continuous improvement plan. You ensure that production practice are aligned with validation conclusion. You manage quality trend analysis, quality reviews on the system. You contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities.

Profile:

Experience in FDA environment requested Former relevant industrial experience or equivalent in pharmaceutical Prod., Valid. or QA in a biopharmaceutical. Relevant experience in GMP, CFR, Eudralex A previous experience in a QA department is a real asset. Analytical review of GMP documents University degree in Science (Pharmacist, Engineer or equivalent.) English & French

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