CSV Consultant, CSV Consultant, CSV Consultant

scaling-up, ultra filtration and centrifugation techniques for finished product.

fingerprint forms, scientific testing of items from scenes of crime.

MES (Werum Pas-X) implementation, Flexlink Copa Data Zenon Platform & DiVAL (Digital Validation), SAP ERP, Veeva Vault and Text
Verification Tool (TVT) Project
Development of Automation platform globally: SOPs, Plans, Change Control, Validation Strategy, Data Integrity & Risk/Impact Analysis

EDMS implementation.

SAP MDG Pilot Program. Coordination of test team, documentation, and test strategy using PIMS (Valgenesis).

Validation/Remediation of all CSV IT practices using Microfocus ALM for SAP S4 Hana roll out and deployment, including GRC, Proxima
DACH, 6River AMR (Auto Mobile Robots), and Change Management.

Validation and QA of all CSV IT practices for eWOW project including SAP S4 Hana, and Solman, including MDG, GRC, ADM and
Tricentis TOSCA.

Validation and QA of all CSV IT for: Global Sparta CAPA Digital Trackwise, Plato e1ns FMEA SaaS, Siemens MES (Opcenter), Fastec
MES (Helium Decay), Ipcos Membrane Data Analytics, Articulate 360 LMS, SailPoint IIQ IAM, AKKA Xray Irradiation, CARL CMMS,
Tricentis Tosca Test Automation, SAP ERP / Solman and USDM Docusign Platform.

Management of CSV IT processes for FDA Inspection Readiness Program. Remediation of AEMS (ARISg), eTMF/Veeva, eDMS, SIMBA
and ICSR pharmacovigilance systems.

Medical Device Software Remediation & GAP analysis to ISO 13485:2016. Coordination of Black Box Testing for PLC's, HMI's and
SCADA.

Management of all Automation CSV test practices for the Burgwedel V920 (Ebola Vaccine) Project. Validation of all Autoclaves, Filter
Integrity Testers, ViCell Cell CounterS and EMS (Lighthouse Environmental Monitoring System).

Validation and Project Management of all CSV IT practices using agile methodology for the LEAN Global S4 HANA / ERP Health Care
Project. SAP Business Process Requirements (BP & BPAC) during User Acceptance/PQ Test Phase for multiple Releases / Deployment.
Test & Risk Management: FMEA, Usage of Jama (Atlassian) & HPALM testing software.

Management of all CSV for the New Generation Manufacturing Automation project. Defining the Corporate CSV Automation test
strategy including Emerson DeltaV DCS, Syncade, PI Osisoft and Infobatch.

Data Integrity Remediation Program; FDA 483 Warning Letter. Risk Assessments, Review and Action Plan for site Computerized
Systems. (PLC, SCADA, HMI for Pin Hole Detectors and IPC/ Filter Integrity).

Management of CSV IT processes for ServiceNow Global roll out and deployment.

Management of CSV processes for EUAFME Streamlink project, comprising of global SAP S4 HANA/ ECC 6.0 roll out / deployment and
HPQC/ALM validation.Planning, scripting and reporting of SAP test track for non GXP/SOX & GXP covering, modules (O2C, M2D, P2P,
and ICO), PDD's and WRICEF's.

(See above for details, as also contracted to other clients during this period : Roche, Biogen & Friesland Campina)

GMP & GAMP5 advisory/guidance to company on Summit project: Global SAP S4 HANA /ERP/ ECC roll out and HPQC/ALM validation
Provision of support and guidance for all qualification activities, trouble shooting, defect resolution, technical support and project lead.
Implementation of the following for SAP ERP 6.0 solution: Supply Chain Scheduling, Master Data Governance, Global SAP & IntegGRC
Governance Risk & Compliance. Modules (APO, MM)

Validation Management of IT test process, data integrity, deviation management, project management, remediation, infrastructure
qualification, quality and compliance. Responsible for timely completion of the following projects:
* SAP Transition; PAS-X (MES) Implementation SAP /PRISM-COCPIT Interface implementation
* Symantec Enterprise Vault/Email Retention (Legal Hold & PST Migration & Archiving)
* SOP Template Project (MS Word 2010 add-in) Win 7Up Virtualization Project (IE6, IE8, IE9 & Desktop)
* Microsoft Lync 2010 Unified Communications Microsoft Project 2010 Upgrade
* Active Directory Federation & Domain Service PIM (Privileged Identity Management)
* Implementation of ITUS Solution (Iran-US embargo for Corp. Operations)
* NetBackup & Backup Data Migration Sharepoint, MS Lync & MS Office upgrade.
Each project loaded with full lifecycle deliverables. Provision of testing estimates, individual tasks and project management.
Reporting to senior level personnel and stakeholders. (Directors and Managers)

Also responsible for Test/Tech/QA support to the following projects; Regulatory (R.I.M.S/Remedy; Register/ArisGlobal) incident backlog
reduction, Future NovoDocs, OmniRIM Empower3 QA review, Configuration Review Reporting (CRR), CTMS for Ferring Pharma (Clinical
Trial Management System), Glucagen Serialisation, CSV Remediation, DataStage Migration & Tool, MS Office 365, Citrix Upgrade and
ITSM (IT Service Management/ BMC Global Remedy). QA support of Change Requests & Supplier Assessments; stakeholder and
customer liaison, working to principles of ITIL, GxP, 21CFRPt11, & GAMP5.

Prospective-validation of all Laboratory systems for critical product release in Japan.

Lotus Notes/Domino R6-R8 Upgrade & N(i)2 Configuration Management Database (CMDB) Implementation Projects
Management of vendor testing processes including documentation, test team, quality and compliance. Prospective validation of IT
systems. Management, writing, execution and review of Full Lifecycle Validation/UAT Protocols (VMP, FRS, URS, RTM, RA, IQ, OQ, PQ,
VS, Use Cases)

KalOmega Project; Factory & Site Acceptance Testing (FAT/SAT) of all Pipe work modules during first phase site construction. NCR's,
Deviations, P& ID's, Isometrics, Punchlists, Full Pipework & Supports Inspection, RTM's, Welding QA/QC/NDT.

CSV Validation Project; Prospective-validation of all Laboratory IT systems (LabX, AKTA Unicorn, Spectrum 100) to 21CFR Part 11 &
211; Writing of Qualification Protocols (URS, QP, IQ, OQ, PQ, VSR)

Retrospective-validation of Site wide Nitrogen & Compressed Air Systems.

Digibind product using Agilent 1200 HPLC/Atlas & Mettler DL55 Autotitrator/LabX. Assay/ Method development

Capsules, Tablets & Granules-Augmentin/Amoxicillin products) & Production of Annual Periodic Reviews

specifications. Analysis of raw materials and final products

Belhaven Brewery, UK, Laboratory Assistant, QA testing of beer.