Monsieur PI... E.......
Secteur d'activité actuel : Pharma
Taille de l'entreprise : + de 1000 salariés
Fonction actuelle : Quality leader
Nombre d'années à ce poste : 1 à 2 ans
Nombre de personnes sous mes ordres : 0
Salaire annuel : 0.00 EUR
Expérience Totale : + de 15 ansDisponibilité : Disponibilité immédiate
Fonctions: responsable assurance qualité, ,
Secteur d'activité: laboratoires centraux, laboratoire d'analyse médicale, pharma, ,
Type de contrat souhaité: CDI, CDD, CDD Intermittent, Interim, Agent
Temps de travail souhaité: Temps plein, Temps partiel, En alternance, Journalier
Salaire Annuel Minimum / Souhaité: 0.00 / 0.00 EUR
Dernier niveau d'etudes validé avec diplome : Bac+4
Dernier diplome :
Niveau d'études actuel : Bac+4
Autres Formations :
Pays : France, Suisse
Outils / Logiciels / Méthodes maitrisés
Permis VL, PL, véhicules spéciaux
Français : Langue maternelle
Anglais : Langue de travail
Monsieur PI... E.......
Quality AssuranceWORK EXPERIENCE
professional with over 17 years’ experience in Life Sciences principally
dedicated to Clinical trials in areas such as quality assurance, compliance,
data analysis, validation and qualification of laboratory instruments, problem
solving quality issues (CAPA), training. My strengths include a creative
approach to problem solving, change management with a strong commitment to
F. Hoffmann-La Roche Ltd., BaselAug
2016 – Feb 2017
Leader (as a contractor)
Product development Medical Affairs (PDMA) staff with compliance support to
ensure that all medical affairs activities are conducted in accordance to the
Roche SOPs, guidelines and policies.
Quality management support to PDMA and the Affiliates, and deliver a quality oversight
plan and metrics.
on annual update of the QMS Handbook for individuals involved with GCP and GVP
Self-inspections: Pharmacovigilance audits (Additional Monitoring; Market and
Patient Support Program (MAP), Study Management audit (Inform Consent forms
(ICF); Trial Master Files)
and update the 2016 Quality Plan for Good Clinical Practices (GCP) and Good
Pharmacovigilance Practices (GVP) in PDMA.
GCP/GVP training in PDMA to new hires according to the PDMA Training Matrix and
the PDQ Global Medical Compliance Training Grid.
Covance Central Laboratory Services
SA, Geneva1997 – 2015
Quality Assurance Senior Auditor 2012 – 2015
schedule, conduct, report and close audit activities: >= 20 audits/year
(Internal Audits, Suppliers Audits,
hosting Client Audits)
Maintain the Quality Management System (QMS) in
compliance with Covance QMS guidelines or any applicable regulations or
Evaluate audit findings and
write reports to operations staff, management, and customers.
Develop and implement communication and action
plans to prepare for ISO 15189 accreditation => ISO 15189 accreditation was
granted in 2013.
· Proposed criteria to run management
meetings more efficiently.
Serve as author or reviewer
of Quality Assurance SOPs.
consulting/teaching on the ISO standards (15189; 9001; 17025)
Present GCP program and provide
training to operational staff on compliance procedures.
Quality Analyst 2009
Responsible globally for the management and
analysis of quality issues:
Utilizing appropriate problem solving skills,
track to resolution all issues reported from internal and external sources.
investigation teams during investigation of Corrective Actions for Issue
Resolution (CAIRs) and reportable issues to drive root cause analysis and
effective corrective and preventive action plans (CAPA).
Provide monthly reports to Worldwide Quality
Lead initiative to improve efficiency of
Quality Tracking Management complaint (QTM) process and differentiate QTMs
based on risk criteria: Introduced risk criteria to
differentiate severity and allow prioritization of resources to address the
most significant issues.
Ø Reduction in time
completing/processing QTMs: 252 hours for the business => 31% savings.
· Leader of Geneva Signature
Client Services (SCS) initiative to promote a company culture for customer
satisfaction (6 subordinates) => event presentation to 500 participants
Laboratory Manager & Laboratory Compliance Analyst 2002 – 2009
Provided programming support to laboratory departments worldwide to
maintain performance of the laboratory activities which includes to create
statistical analysis tables, performing checks on clinical data for possible
discrepancy, develop new reports to monitor quality tasks.
Gap Analysis and Gap Assessment for each of the laboratory systems to maintain compliance with the 21CFR
Part 11 Rule, ensure implementation of IQ/OQ/PQ, developed validation
documentation for instruments, worked with vendors of instrumentation, worked
with QA Staff to ensure that compliance is sustained.
Manage and Supervise
five individual team members.
Lead as a Green
Belt a Kaizen project (six sigma approach) to reduce delay for generation of the Quality Control reports.
management of global data combinability for all assays tested worldwide.
resource time needed to generate QC reports by 8%.
material/new releases and provided training to new employees/supervisors to
more than 150 employees (PeopleSoft Purchasing & Inventory, Rees Centron
System, General Lab training, Trackwise)
level of Basic QCs Practices and Westgard rules training done to supervisors in
Europe and USA from 3.2/5 to 4.5/5 after training.
Laboratory Central Coordinator 1999
and maintenance of all technical installations in the laboratory.
of security training in Lab; develop, implement and report
Maintain a high
level of coordination and liaison between Laboratory and others departments and
Covance Laboratories worldwide.
Laboratory departments during customer visits and audits.
Medical Technologist 1997 - 1999
testing, ensuring validity and reliability of results, optimizing reagents
management and maintaining equipment.
Pierre Fabre Laboratoire, St Julien en Genevois,
Medical Technologist in a R&D department
Merck-Serono, Aubonne, Switzerland 1989
purification of proteins(recombinant of human growth hormone (r-hGH))
of recombinant human FSH & LH by a sequence of chromatographic steps
EDUCATIONEDUCATIONCertified Lean/Six Sigma Green Belt, Covance CLS, 2009ADDITIONAL TRAINING
Certificate in Computer and Multimedia, CFPPA, Pezenas, France, 1995
Certificate in the use of Material Requirements Planning (MRP II)
system to optimize inventory replenishment operations, Inceltech, Toulouse,
of Sciences, degree in Sciences and Techniques, Grenoble
& Corte University, 1988
ICH GCP Principes – 2011
21 CFR Part 11: e-Records
& e-Signatures – 2011
(CQA) Fundamentals I, II, III – ASQ Class 2013
Global Security Awareness
Training – 2013
Resolution: Issue Investigation and Corrective and Preventive Actions with
Effectiveness – 2014
15189 Walkthrough, ISO 15189 Auditing, ISO 15189 Management Review – 2014
9001:2000, QMS – 2014
course “How to conduct GCP inspections/Audits at the Clinical Investigator
Site” – 2015
course “Pharmacovigilance Drug Safety” – 2016
LANGAGESFrench: native speaking
MS Office, Minitab, FrontPage, PeopleSoft, Trackwise, SharePoint, iLearn, LIMS
Monsieur PI... E.......
Monsieur PI... E