QA Coordinator – Transversal Validation & product Transfer

Région
Wavre
Publication
lundi 11 septembre 2017
Date limite
mercredi 11 octobre 2017
Réf
71DCAXPE-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 Coordinator – Transversal Validation & product Transfer 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:

Perform QA review for validation related to product transfer and clinical batches Provide QA support to validation activities performed in a project Take the responsibility for QA in validation activities Provide a compliance expertise in Validation Acts with colleagues of TRD and production team, and Primary / Secondary Quality Assurance Team (commercial site, TRD) to ensure product transfers are in line with GSK business objectives to meet customer needs. Manages quality assurance activities in the Product Transfer Process as part of the GSK Vaccines network through the application of key business and GMP processes in line with the strategies, policies and standards of GSK Vaccines. Approve the relevant validation strategy from phase I to the commercial operation (commercial consistency lots) Approve the respect of validation evidence in the process development value stream (PDVS) concept. Verified the alignment of the validation from TRD early phases to commercial operation Review product/process validation items to assure that deviation from plans and any others issues are proactively identify and correctly solved Approve the link between the FMEA and the different risk assessments (TRA, PRA) and their corresponding validation documents. Approve the Validation plans.

Profile:

You have an University degree (Biotechnology, Agronomy, Chemistry or Pharmacy). You have an experience in product and process validation (2 years minimum) and at least 5 years of experience in Prod., Valid. or QA in a biopharmaceutical industry. You have a good Technical knowledge in pharmaceutical industry (equipment, processes). You speak fluent in 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