PAGNIEZ Martial +33 683242931 cell phone mp1049b2a@westpost.

net Summary: After 1

0 years experience in Software Engineering and 5 years experience in Soft ware Q
uality Engineering in military and avionic project, received a Masteras De gree
in Software Engineering related to ERP Systems on Production Management. O ver 1
5 years as a Computer Systems Validation Consultant and MES Consultant (SAP MM/P
P-PI, Rockwell, Werum systems) for the major pharmaceutical companies in Eu rope
and USA. Professional Experience: BD Grenoble Project Manager April 2010 In cha
rge of defining budget for BMS (Building Management System) revamping Genzyme Fr
ance MES consultant March 2009 March 2010 In charge of URS and workshop to deplo
y MES PASX Werum and Warehouse Management System. Support and train end users. W
arehouse management system deployment: a Warehouse mapping: storage location, st
orage bin a Interface with ERP mfg/pro a Material Management activities: o Setup
material master data such as material type, statuses and expiry date cal culati
on, storage location. o Draw up business procedure such as raw material purchasi
ng, goods receipt, mat erial transfer, goods issue and Inventory management. o C
onfigure business scenarios and perform test (data test creation) o Draw up trai
ning material o Train end users. a Setup terminals, PDA scanners and printer lab
els. a Perform IQ and SAT tests of business flow such as good receipt, good issu
es, g ood movementsa GE healthcare BUC France Global IT Quality Coach April 2008
a"Dec 2008 a Objectives: o Qualify Validation Manager for EMEA. o Perform train
ing on CSV procedure. o Provide guidance to validation team and functional team.
o Review validation documents for the major applications. o Ensure audit readin
ess. o Support FDA mock inspection. Wyeth Ireland MES Consultant Jan 2006 until
Dec 2007 Major achievement: Implementation of Electronic Batch Record based on P
MX of Pro pack-Data interfaced with SAP MM/PP-PI, PI-Sheets and automation throu
gh OPC Ser ver Activities: a Maintain Material Master data for Compression, Solu
tion Prep and Coating opera tions a Maintain SAP recipe and PI-sheet, BOM and ma
terial statuses, Process order and Batch record.
a Setup QM In Process Control a Develop EBR for Compression, Solution Preparatio
n and Coating operation, from Recipe, operation to Process Order execution. a De
velop training material. a Support MES team for compliance issues and validation
activities. IBM Israel for Perrigo Pharma Company Nov 2005- Dec 2005 a Train an
d coach IBM consultants in Best Practices for pharma industry (MM/PP-P I,PI-Shee
ts and QM) for Procure to Pay and Make to Stock processes including Ba tch Manag
ement integrated with QM a Prepare work plan for blueprint activities. UCB Pharm
a (Harvey Nash) Belgium Compliance Consultant Jan 2004 -October 2005 a Review al
l validation documents, risk assessment, validation plan, test sheet execution a
nd report, ensure audit readiness. a Support and coach SAP team to capture and v
erify business requirements, to spe cify business processes and to validate them
on risk based approach mainly on MM /PP-PI/WM/QM modules a Test Marshall in Roc
hester USA for SAP testing (OQ and data migration) for MM/ WM/PP-P, PI-Sheets in
tegrated with QM processes such as Material Management pro cesses (inventory & w
arehouse) Purchase to Pay, Supply Chain Replenishment and O rder Fulfillment. a
Project Framework Trainer: Project Management, Project execution and Validatio n
(System Blueprint, System Testing) Merck (MSD) France Nov 2002 -Nov 2003 Projec
t Manager for implementation and validation of Electronic Batch Record in manufa
cturing area (MES: PMX of Propack-Data), cGMP and 21 CFR Part 11 complian ce. a
Review of all documentation, manage meeting with related end users, manage the p
lanning and supervise all validation activities (IQ, OQ, PQ). Watson Laboratorie
s California (Washington Group) July -Oct 2002 Computer System Validation Consul
tant a Laboratory operation and R&D validation of computer with instrument HPLC,
GC/G CMS, FTIR, Vankel dissolution system, electronic record on GMP server. San
ofi Synthelabo Research France June 2002 a Trainer on 21 CFR Part 11: "The keys
interpretation and assessment questionnai re": The attendees were able to assess
all computerized system according to the questionnaire based on 21 CFR Part 11
and Sanofi policies. Watson Laboratories California (Washington Group) Aug-2001
- May 2002 Computer System Validation Consultant a SAP PM/MM validation, data mi
gration verification a Implementation and validation of Laboratory Information S
ystem (SLIM and SLIMS TAT+ of H&A Scientific) for Stability Department including
: - User Requirement, System Specification, Risk assessment, Traceability Matrix
- SOP: System Administration, backup and recovery, - IQ, OP, PQ protocol, - Fin
al report.
Hewlett Packard France Feb a"July 2001 a Integration and validation for a new ME
S for PC assembly interfaced with SAP M M and WM from customer order, picking ar
ea, assembly and packaging lines to deli very finish goods. a Maintain Material
Master Data, BOM/Routing, Process order. Pfizer, BMS France 2001 (3 weeks) a Per
form GMP audit and specify how to implement Electronic Batch Record integra ted
with legacy systems SAP MM, WM and POMS (dispensary system). a Analyze the major
GMP processes and their related documents and records: Purchase Order, material
receipt, status management, inventory management, Requi sitions Order, Transfer
Order, dispensing management, material consumption. CyberConseil Lyon France Co
nsultancy Company 1996 - 2000: Computer System Validation Consultant Expertise a
rea: - ERP :( Material Master Data, Master Recipe, Material Status) Protean (Mar
cam), mfg/pro (QAD), SAP (MM WM PP-PI) with POMS (dispensary system), end user t
raini ng in production and material management - LIMS (SLIM), Building Managemen
t System, Clean Room Monitoring - DCS Fisher, ABB, PLC Siemens, SCADA Intouch, F
IX ... - Lab instrument HPLC, GC/GCMS, FTIR, Dissolution system - Regulation and
Standards: -cGMP 21 CFR 210/211, GCP, GLP, 21CFR11 assessment and remediation -
IEEE 830-1998 (Software Requirements Specifications), SPICE (ISO/CEI 15504). -GA
MP4 - Develop methodology of system engineering and computerized production syst
em ( Development of Template such as URS, SRS and functional system) - Develop v
alidation strategy based on risk analysis and traceability matrix - Perform all
validation activities: - Generate Validation Master Plan and Validation plan, -
Perform risk analysis and appraise of advance acceptance criteria, - Draw up SOP
s for end user, maintenance, - Manage Traceability Matrix, - Draw up all protoco
l: IQ, OQ, PQ, - Supervise the execution of all qualifications, - Manage Non con
formity and related changes with suppliers, - Write the final report. List of re
ferences: ASP (groupe AstraZnca), Aventis Pasteur/Pasteur Mrieux Connaught, Baye
r Pharma, Barriquand Striflow, Beaufour Ipsen Industrie Clinique, BioMrieux, Chi
mex, Ethyp harm, Hoechst Marion Roussel, Lilly France, LaOral, Marion Merrell Bo
urgoin, Par ke-Davis, Pharmacie Centrale des Armes, Pfizer, Piston de Colmar, Rh
odia, Rhne-P oulenc Biochimie, Rhne-Poulenc Chimie, Rhne-Poulenc Industrialisati
on / CRIT, Rh ne-Poulenc Rorer, Roquette Fr*res, Sanofi-Synthlabo, Sanofi Winthr
op, Silicom, S olvay Peptisyntha, SkyePharma. 1989-1995 Focal Groupe OUROUMOFF :
Software House - Project manager especially in critical projects: aeronautic, m
ilitary - Quality Assurance Manager: IS0 9001 1984-1989 Elect Industrie Engineer
ing company - Project management especially in automation
1981-1984 CORECI process control and instrument Manufacturer - Management Studie
s in Advance Process Control in R&D 1976-1981 ELF FRANCE - Refinery - Maintenanc
e Management Education and Training: 2007 May 5 days training course SCM340 Proc
ess Manufacturing 2002 Nov 5 days training on MES of Propack-Data Germany 2002 J
an SAP Academy France MM Intensive course 5 weeks: MM Processes, Procurement / C
ross Functional Customizing, Materials Planning, In ventory Management / Physica
l Inventory / Cross Functional Customizing, Valuatio n and Account Determination
, Invoice Verification, Classification & related area s in MM / Batch Management
, ASAP, IMG / Cross Functional Customizing 2000 Business English course: Eurocen
tres Business Institute London 1996 Advanced Diploma in science: (DESS) Software
/Image/Production Option Enterp rise Resource Planning: University of Lyon 1980-
1989 Certificates: Mathematics, Software Engineering, and Numerical Analysi s: C
NAM Lyon 1975 BTS Automation and instrumentation AFPA Paris