Project Manager QA

Région
Wavre
Publication
mercredi 15 mars 2017
Date limite
samedi 15 avril 2017
Réf
692B6XPE-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: Project Manager QA Organisation description: Job description:

Provide QA support to QC department (Biochemistry or Physicochemistry or Center of Technical and Product expertise). Act as back up of the Manager QA Operational Ensure QA representation in QC task force meetings Manage complex technical problems, evaluate potential impact on product quality and escalate to management Review and challenge the QC deviations and CAPA of its QC department Escalate L1 deviation Approve QC deviation and related CAPA in accordance with procedures and timelines Ensure the implementation of CAPA Review and challenge the QC change controls in accordance with procedures and timelines Approve QC changes and ensure that they have been approved by adequate people in accordance with procedures and timelines Approve QC SOP related to its QC department in accordance with procedures and timelines Review, challenge and approve the stability protocol and report in accordance with procedures, QMS requirements…and timelines Perform QA on the floor program in QC Report any major event to its QA manager

Profile:

Bioengineer/Pharmacist or equivalent Good knowledge of current Good Manufacturing Practices and Stability studies Good manufacturing and laboratories process knowledge Good knowledge of English (written and spoken) 5-10 years experience in pharmaceutical environment Experience in FDA/EU/WHO inspection Good knowledge of FDA/EU/ICH/CDN/AUS guidelines Quality Control experience Experience in biologicals manufacturing/testing processes



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