CV of Quality leader / Responsable assurance qualité , looking for a job of responsable assurance qualité / suisse.enligne-ch.com

Current industry: Pharma

Size of the company: More than 1,000 employees

Current position: Quality leader

Number of years spent at this position: 1-2 years

Number of persons you managed: 0

Annual salary: 0.00 EUR

Total working experience: more than 15 years

Availability: Immediate availability

Positions: responsable assurance qualité, ,

Industry: laboratoires centraux, laboratoire d'analyse médicale, pharma, ,

Desired type of contract: open-ended contract, fixed term contract, Fixed-term / casual work, Temporary work, Agent's contract

Desired working time: Full-time, Part-time, Study-work program, One-day assignments

Minimum annual salary desired: 0.00 / 0.00 EUR

Highest educational level completed: number of years studied and completed with a diploma after highschool : +4

Last diploma :

Current educational level : +4

Other training courses :

Geographical mobility: Country : France, Switzerland

Known Tools / Software/ Methods

HGV, LGV, special vehicles licences

Languages French : Native
English : Working language

Mr. PI... E...

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1290 VERSOIX
Switzerland

Quality Assurance
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
customer focus.

WORK EXPERIENCE

EXPERIENCE

F. Hoffmann-La Roche Ltd., BaselAug
2016 – Feb 2017
Quality
Leader (as a contractor)
·
Provide
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.
·
Provide
Quality management support to PDMA and the Affiliates, and deliver a quality oversight
plan and metrics.
·
Worked
on annual update of the QMS Handbook for individuals involved with GCP and GVP
activities.
·
Performed
Self-inspections: Pharmacovigilance audits (Additional Monitoring; Market and
Patient Support Program (MAP), Study Management audit (Inform Consent forms
(ICF); Trial Master Files)
·
Worked
and update the 2016 Quality Plan for Good Clinical Practices (GCP) and Good
Pharmacovigilance Practices (GVP) in PDMA.
·
Assigned
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
·
Plan,
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
standards.
·
Evaluate audit findings and
write reports to operations staff, management, and customers.
ð
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.
·
Provided
consulting/teaching on the ISO standards (15189; 9001; 17025)
·
Present GCP program and provide
training to operational staff on compliance procedures.

Quality Assurance,
Quality Analyst 2009
– 2012
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.
·
Supported
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
management.
·
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.
·
Performed
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.
Outcomes were:
Ø
Improve
management of global data combinability for all assays tested worldwide.
Ø
Decrease
resource time needed to generate QC reports by 8%.
·
Developed
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)
ð
Improved
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
– 2002
·
Ensure control
and maintenance of all technical installations in the laboratory.
·
Ensure follow-up
of security training in Lab; develop, implement and report
lab KRI’s.
·
Maintain a high
level of coordination and liaison between Laboratory and others departments and
Covance Laboratories worldwide.
·
Represent the
Laboratory departments during customer visits and audits.

Medical Technologist 1997 - 1999
·
Performing Immunology
testing, ensuring validity and reliability of results, optimizing reagents
management and maintaining equipment.

Pierre Fabre Laboratoire, St Julien en Genevois,
France1996
Medical Technologist in a R&D department
Merck-Serono, Aubonne, Switzerland 1989
– 1993
Medical
Technologist
·
Production:
purification of proteins(recombinant of human growth hormone (r-hGH))
·
R&D: purification
of recombinant human FSH & LH by a sequence of chromatographic steps
(pilot).

EDUCATIONEDUCATION

Certified Lean/Six Sigma Green Belt, Covance CLS, 2009
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,
France, 1995
Bachelor
of Sciences, degree in Sciences and Techniques, Grenoble
& Corte University, 1988

ADDITIONAL TRAINING

·
ICH GCP Principes – 2011
·
21 CFR Part 11: e-Records
& e-Signatures – 2011
·
Auditing
(CQA) Fundamentals I, II, III – ASQ Class 2013
·
Global Security Awareness
Training – 2013
·
Issue
Resolution: Issue Investigation and Corrective and Preventive Actions with
Effectiveness – 2014
·
ISO
15189 Walkthrough, ISO 15189 Auditing, ISO 15189 Management Review – 2014
·
ISO
9001:2000, QMS – 2014
·
E-Learning
course “How to conduct GCP inspections/Audits at the Clinical Investigator
Site” – 2015
·
E-Learning
course “Pharmacovigilance Drug Safety” – 2016

LANGAGES
LANGAGES

French: native speaking
English:
professional proficiency

COMPUTER SKILLS


COMPUTER SKILLS
MS Office, Minitab, FrontPage, PeopleSoft, Trackwise, SharePoint, iLearn, LIMS
(Envision)

Mr. PI... E...

....

1290 VERSOIX
Switzerland

Emploi de responsable assurance qualité en laboratoire médical

Je suis activement à la recherche d’un emploi depuis
février 2017, et même si j’ai 55 ans je suis certain que mon expérience en
assurance qualité servira parfaitement pour le poste mis à pourvoir.

J’ai passé plus de 17 années chez Covance CLS à
Meyrin, d’abord au sein du laboratoire dans les départements de l’immunologie
et du laboratoire général, avant de travailler dans l’assurance qualité : Maintien
et amélioration du QMS; planification et réalisation des audits internes et
externes; assurer la revue documentaire
(procédures, instructions de travail, manuel qualité); responsable et suivi de
la gestion des dysfonctionnements (CAPA, amélioration continue); formation des
équipes au GCP & GCLP; réalisation des revues de direction; très bonnes
connaissances en ce qui concerne l’assurance de conformité aux exigences réglementaires
et normatives (ISO 9001, ISO 15189, ISO 13485, FDA 21 CFR part 11).



Avant de travailler dans le domaine
de la qualité pour Covance et récemment pour Roche à Bâle, j’ai débuté ma
carrière professionnelle en production chez Ares-Serono (Merck) à Aubonne. J’ai
acquis et suivi les connaissances nécessaires en GMP que demande l’industrie
pharmaceutique. Je m’occupais de réaliser la purification complète de l’hormone
de croissance humaine recombinante essentiellement à partir d'étapes de
chromatographie, avant que la molécule soit liophylisé pour la mise en forme
pharmaceutique.

Je souhaite aujourd’hui apporter mes connaissances
techniques dans le domaine de la qualité, mettre en application mon niveau “Six
Sigma Green Belt” et améliorer le système de management de la qualité de l’entreprise.

Dans l’attente de votre contact, je vous prie d’agréer, Madame, Monsieur, l’expression
de mes salutations distinguées.

Mr. PI... E