QA Validation Expert

Région
Wavre
Publication
vendredi 11 août 2017
Date limite
lundi 11 septembre 2017
Réf
70E42XPE-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 Validation Expert 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:

The QA Validation Specialist is part of the QA Operations for one MPU. You ensure the QA oversight of the continuous validation activities for one or several production units within one MPU. Mains objectives of this function are: To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP), To define the validation strategies through the change control process (RPC), To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis), To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV), To ensure the correct application of the validation quality systems on the field and to define improvement plan as required, To support the production & technical services teams in the implementation of the validation activities, To ensure the adequate management of validation deviation (be QA GMP Responsible) and potentials CAPA (be Compliance Authority). Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the GSK Vaccines standards and procedures. Your day to day: Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the GSK Vaccines standards and procedures. Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA). Maintain a capacity management of the resources needed to implement the quality commitment within the CVP and manages the potential lack or tradeoff with the support of its management. Support from a compliance point of view the MPU Product&Process, Production and QA Operations for validation topics. Build a strong partnership with these key stakeholders. Support the validation approach and decision during internal and external inspection and prepare the strategy of defense with MPU Product&Process, Production and QA Operations.

Profile:

You have a University Degree in biotechnology, agronomy, chemistry or pharmacist. You have knowledge of good practices in bio-pharmaceuticals, of different regulations and standards related to validation activities. You understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety. You use a risk based approach for problem solving and prioritization of tasks. Blow a quality and compliance mindset through the validation activities to be a good team player in order to success in each validation project. You have a experience in production, validation or QA in the biopharmaceutical industry.

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