Patrice PELKA

En résumé

Entreprises

• Sanofi - QA Senior Manager

  Paris 2015 - maintenant Produits injectables stériles et collyres stériles
  Gestion des activités de libération
  Compliance (réclamations, déviations, change controls)
  Gestion de la documentation et des formations
  Audits internes et inspections (FDA, EMEA ...)
  Gestion des campagnes de fabrication grippe
  
  Résultats :
  Réduction du nombre de déviations ouvertes de 25%
  Augmentation de la productivité (+30% de dossiers revus/libérés par jour)

• Pierre Fabre Médicaments (sub contracting) - Compliance Manager (QA Associate Director)

  2011 - maintenant Regulatory affairs
  Management of Audits and inspections (about 10 a year)
  Release (supervision of 1 manager + 1 technician)
  Documentation and training (supervision of 1 manager + 3 technicians)
  Management of periodic reviews
  Project leader for a QMS software
  
  Achievements :
  Attendance to the close out of a warning letter
  Revamping of the change control and CAPA processes
  Cleanup of backlogs (over 340 change files closed out in 2011 and 600 CAPAs closed out in 2012)
  Revamping of the Annual Review process and planning (15 files late over 35 in 2010)
  Put in place of dynamic trending for 22 products
  Positive feedback for all our customers (15 international companies)

• GSK Biologicals - QA / Validation Manager

  Marly-le-Roi 2007 - 2011 Validation team building (injectable and oral vaccines)
  - lead and development of teams from 5 to 21 engineers & technicians
  - continuous imporvement of the validation processes and planning
  - training of the Staff
  - put in place of periodic revalidation
  - definition and setting of Department objectives
  
  Expert for capping (grade A), depyrogenization, autoclaving, automated visual inspection
  
  Setup of FMEAs as validation optimization tool and as knowledge management method
  
  Budget from 450 kE to 2 ME
  
  Results :
  - validation number x3 vs team size x2 the first year (Greenbelt for 6 sigma & Lean manufacturing)
  - green belt project for the improvement of the validation performance (twice the validation number in the 1st year : linked to both hiring and validation improvement)
  - execution rate of planned activities risen from 35 % to 90%
  - level of team's training risen from 40% to 90 % in 1 year
  - closure of backlog deviations + validations
  - successful audits and inspections (FDA, KFDA, Japan, DGM ...)
  - Setting of KPIs

• SANOFI - Project Manager (Consultant)

  Paris 2006 - 2007 Revamping Project Manager (injectable vaccines)
  * Budget of ~3 ME (1.6 ME investment / 5 engineers / 20 workers / half building revamping)
  * Piping revamping for 21 serotypes purification step (4 areas)
  * Revamping of the Builfing Management System (process, environment ...)
  * Revamping of chromatographic tower systems + building of the Chromatographic system network.
  * Put in place of a clean in place for chromatographic towers
  * qualification / validation of the modifications
  * management of the building shutdown
  
  Results :
  A 1 year planning followed with no late
  Budget kept at -2 % (all requirements done)
  
  Evaluation for the installation of a new purification area
  - URS
  - feasability
  
  Results :
  studies done

• Beaufour Ipsen - Quality Officer

  2001 - 2006 Quality Officer (oral drugs : tabs, powders and liquids)
  Put in place of validation / qualification system (SOPs, training, VMP, User Request Specifications, product performance evaluation -stats-)
  Coaching of the projects leader to Quality By Design
  Qualification / validation
  
  Senior Auditor
  Manufacturing investigations
  
  Project leader for industrial transfers (from site to suppliers) / Transversal management
  
  Budget of 300 kE
  
  Results :
  - validation system in place / in use
  - pilots for Periodic validation / validation traceability matrix / FMEAs
  - audits of foreign suppliers (Ireland, Netherlands, germany ...)
  - successful AFSSAPS inspections
  - statistical evaluation of the manufacturing processes

• Ipsen Pharma Biotech - Validation engineer

  Boulogne-Billancourt 1999 - 2001 validation / Qualification (Dry freezed sterile injectable products)
  Expert for process & analytical validations (sterilization, gamma sterilization, cleaning, Dry freezing, chromatographic systems, LAL analyzer ...
  HVAC
  utilities (including WFI)
  production equipments
  packaging equipments (inspection machines ...)
  
  Auditor (beginner)
  
  Routine and PAI inspections (FDA & AFSSAPS)

Formations

• Institut D'Administration Des Entreprises I.A.E. de Paris

  Paris 2004 - 2006 business management
  
  half time studies, after job time

• ENSCCF

  Aubiere 1995 - 1998 Chartered Engineer (MS Industrial Processes)
  
  Génie des procédés (Industrial processes)

• Ecole Nationale Supérieure De Chimie De Clermont-Ferrand (Clermont Ferrand)

  Clermont Ferrand 1995 - 1998 Chemical Industrial Processes (génie des procédés)