CSV Engineer Consultant
That's XPE. For one of our clients we are looking for: CSV Engineer Consultant 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:
Responsible for providing Data Integrity Global oversight of local & central automation and analytical data systems Facilitate knowledge sharing of completed data system assessments, mitigation, and remediation Review sample of site's DI assessments to ensure completeness and consistency Develop DI remediation program for transversal computerized systems Centralize and analyze DI gaps from site's DI assessments Prioritize remediation projects based on risks, with sites' SI leads Define and lauch High priority DI remediation projects (high risk mitigation requiring strategic solution) Act as central contact point for vendors Support the definition of remediation plans for local systems: deliver guidance to the site's for the remediation and prioritization of typical DI gaps Responsible for providing coordination across Vaccines (GIO/Q) Responsible for providing updates to senior Vaccines leadership Risk Management: Support the risk management process to address data system mitigation and remediation. Knowledge management: Ensure global automation and analytical oversight is delivered and coordinated centrally to maximize mitigation and remediation efforts.Profile:
You have 5 years in the Pharmaceutical industry with significant experience on Data Integrity and automation systems. You demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices and systems. You have project management skills. You are able to engage and influence people from different areas of expertise and to work effectively in a highly matrixed organisation across geographies and cultures. You demonstrated knowledge of regulated environment of pharma / biopharma / vaccines industry. You are able to communicate complex information both orally and in writing. Ability to listen effectively, to understand standard statistical tools, to drive change and to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution. Has the technical competency to evaluate investigations, product issues, etc. Incumbent does not need to be a subject matter expert, but must have the ability to ask questions that lead to the discovery of root causes.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'.
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