QA Validation Expert

Région
Wavre
Publication
jeudi 6 juillet 2017
Date limite
dimanche 6 août 2017
Réf
76ADEXPE-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.

You ensure the QA oversight of the continuous validation activities:

  • 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).
Job description:

You manage QA activities related to one or more Quality systems (ie Deviations, CAPAs, Batch, Release, Environmental Monitoring, Change Control, etc) and relationship with operations.

You maintains and trains SOPs, as required.

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

You 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.

You write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the GSK standards and procedures.

You ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA) and ensure implementation of validation related commitments towards internal and external authorities and organize the follow-up.

You 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 and support the validation approach and decision during internal and external inspection.


Profile:

You have a good knowledges in validation practices, aseptic practices, cGMP and 4 years of experience in validation including QA responsabilities.

You have a University degree (Biotechnology, Agronomy, Chemistry, Engineering or Pharmacy) and good oral and written communication skills 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