Cadre gestion dossiers Validation - Biochemistry 6078

2 jours restants

Région
Wavre
Publication
lundi 26 juin 2017
Date limite
mercredi 26 juillet 2017
Réf
6ECC2XPE-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: Cadre gestion dossiers Validation - Biochemistry 6078 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:

Consultant for the periodic assessment of analytical methods in the Biochemistry group from QC. Produce analytical methods validation documents: Establish strategy for methods to validate in collaboration with supervisor in charge of the method Translate strategy into validation protocol and experimental plan and communicate with supervisor and lab technicians in charge of the method Follow-up of experiments related to validations with laboratories and collect data Redaction of validation reports and submission to Validation Manager and QA Manages and organizes RVA (Re-Validation Assessment) reports production for the entire QC Biochemistry group: Estimation of workload and planification of activities for the entire Biochemistry group Follow-up of established planning Reporting to Biochemistry management Produces RVA reports:: 1. Evaluation of potential drifts in the assay through the analysis of validity criteria history 2. Evaluation of potential drifts in the assay through the analysis of Out Of Specification (OOS) and Out Of Consistency (OOC) results history 3. Evaluation of potential drifts in the assay through the analysis of Batch History and Internal Control 4. Evaluation of potential drifts in the assay through the analysis of the changes made to the assay 5. Evaluation of compliance of existing analytical method validation report with current version of internal procedure for analytical methods validation

Profile:

Scientific degree Bilingual French/English, written compentencies in English Ability to work under pressure due to the requested flexibility and reactivity of the activities Ability to work in project teams in a multidisciplinary environment and a matricial organization Experience in pharma & GMP is an asset Experience in analytical techniques is an asset and knowledge of biochemical techniques (ELISA, MSD-HPLC, gel electrophoresis,…) is highly recommended Confirmed experience in assay management in GMP environment: familiar with concepts such as OOS, OOC, control charts, validity criteria, product quality review, deviation… is highly recommended Confirmed experience in analytical method validation is highly recommended

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