QA Validation

Expire aujourd'hui

Région
Wavre
Publication
jeudi 21 septembre 2017
Date limite
samedi 21 octobre 2017
Réf
72486XPE-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 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:

Provide QA support, oversight to validation activities according to validation procedures and a compliance expertise in validation Ensure QA oversight in validation activities (IQOQ / PQ / PV…) Review/Approve the validation documentation regarding the GMP requirements and the Vaccines procedures Ensure that production practice are aligned with validation conclusion and timely escalation to Management of critical issues during validation Attend all project meetings as QA validation representative 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 Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process To define the validation strategies through the change control process To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….) To ensure the correct application of the validation quality systems in the field and to define improvement plan as required To support the production, QA and technical service teams in the implementation of the validation activities

Profile:

You have a former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry. You have knowledge of GMP / CFR / Eudralex …, of different regulations and standards related to validation activities. Of course you are good communication skills in French & English and an University degree (Biotechnology, Agronomy, Chemistry or Pharmacy). You have knowledge of tools: SAP, documentum.

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