CV créé le :
26/12/2020
CV modifié le :
08/01/2024
Dernière connexion :
08/01/2024
Coordonnées
****
**********
Adresse :
La Trimouille (86290)
Email :
**************@*******.**
Port. :
************
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Validation Lead, Sénior
Référence : 653243
Expériences Professionnelles
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mars 2021
aujourd'hui
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IT Quality, Governance and Compliance Consultant
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KAMAH Consulting
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Helping businesses with their IT compliance projects related to:
Validation and infrastructure qualification,
QMS development,
Process improvement,
System assessments (security, privacy, GxP),
Audits,
IT security,
data privacy
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janv. 2019
févr. 2021
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Validation Lead
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Philip Morris International, Neuchatel, Switzerland
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Directing infrastructure and technical service implementations in line with all time, cost, and
quality requirements. Driving validation of cloud-based infrastructure provisioning platforms (IaaS,
PaaS, CaaS, DBaaS). Perform comprehensive infrastructure qualification of systems, computer rooms,
and data centres.
* Selected as Validation coach, leading content deployment to key internal and external
stakeholders.
* Key point person educating senior executive leadership on risk and impact analysis
recommendations.
* Subject matter expert on Agile and waterfall methodologies for validation and project
management.
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janv. 2018
déc. 2018
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Senior Consultant
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Aston Life Sciences, Lausanne, Switzerland
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Switzerland. Performed in-depth system registration and GxP/Risk assessments. Delivered consultative
guidance to stakeholders, vendors, and team members.
* Built and delivered remediation strategy to minimize operational and technical process gaps.
* Serve as Validation Lead on global ITSM implementation, leading CSV and infrastructure
qualification, as well as multiple Quality System applications.
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mai 2009
déc. 2017
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Senior Regulatory Compliance Consultant
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CTG Europe, Brussels, Belgium
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CTG is an IT consultancy specialising in validation and quality. Principal clients are in the life
sciences and related industries. Functioned as IT Infrastructure Qualification Service Owner
building infrastructure trainings, leading audit planning, streamlining validation documentation,
and performing gap analysis on major processes.
* Executed major consultative engagements (details on page 2) with multinational clientele,
including Oxurion, Ablynx, Baxter, and GSK.
* Subject matter expert for Data Privacy, Information Security and compliance related subjects.
* Spearheaded expansion of scope of services to include data privacy; earned executive buy-in
for key investment and built Data Privacy Service from scratch into a 20-person department.
Experience (Continued)
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janv. 2005
déc. 2006
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Services Ltd, Reading, Project Manager
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Select Early Career
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janv. 2004
janv. 2005
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Project Manager Trainer
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JGA Group, Ruislip, London
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janv. 2001
janv. 2004
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Project Manager
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PRYSMID, Wokingham
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janv. 2000
janv. 2001
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Project Manager
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Edo Limited, Lightwater
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CTG EUROPE
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Built and deployed new governance documentation for CSV, Data Integrity, Risk Management and Data
Protection.
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IT Consultant
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Ablynx, Belgium
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Delivered expert guidance on GxP requirements to IT department for in-house and cloud systems.
Baxter, Belgium - Validation Lead
Performed risk management for privacy and compliance risks to ensure data and security integrity.
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Computer Systems Compliance Manager
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GSK, Belgium
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Lead Auditor for Internal and Supplier Audits; provided expert GxP support to risk management team.
Partnered with QA teams to establish Centre of Excellence practices and enhance computer compliance.
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Diplômes et formations
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sept. 1989
juin 1993
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Informatique
- BAC+4
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University of teesside, uk
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Compétences
Waterfall, Agile, cloud, data centres, Information Security, Data Protection, CSV, IT infrastructure qualification
Compétences linguistiques
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