Quality Support Engineer
Since May 2015
Integrated department : Quality Support In charge of : - SOP reviewal (Batch record management, check-lists, Intercampaign, line clearance) - QA compliance : GAP analysis with legal requirements (Compliance ICH / AFMPS / EMEA / Eudralex) and internal standards. - Risk analysis on line clearance specification - Trainings on updated SOP - Coaching for SOP reviewal with new approach planification and follow-up. - Deviation and events management (ex: C&M failure, entry without controlling parameters, wrong documentation) - CAPA management (ex: implemente new visitors follow-up, documentation mapping) - Audit Level 1 (internal audit) on audit process
Commissioning & Qualification Engineer
May 2014 --- April 2015
Integrated project : Project WN201 - Inactivated Polio Vaccine. Integrated package : Media & Buffer. Equipment : Vessels (Preparation & Hold/Distribution), Filters, CIP/SIP skid, Clean/Black Utilities. Operation Tool used : Delta V. In charge of : - Test sheet preparation for IV/OV in the mechanical department. - Test execution for IV/OV in the mechanical department. - Test sheet review for IV in the mechanical department. - Safety management : Daily safety meeting with subcontractors to communicate on tests/activities with potential risks and safety measures. - Subcontractor documentation review : Isometrics/piping & instrumentation drawing/data sheets review, update and superseed.
Pharmaceutical Engineering Consultant
April 2012 --- March 2015
As a Pharmaceutical Engineering Consultant for Altran, I had the opportunity to work as : - Quality Assurance Associate for Janssen during 2 years. - Commissioning & Qualification Engineer for GSK during 10 months. See below experiences for more details.
Quality Assurance Associate
June 2012 --- May 2014
Context : New EDC (European Distribution Center) for cold and ambiant drugs. GMP activities start followed (repackaging & visual inspection). Tool used : Trackwise, PQMS, SAP. In charge of : - Provide support for operational non conformities : damages, impact assessment on temperature excursion, mix-up investigation, quantity discrepancy investigation. - Perform operational QA activities : quarantine shipments, batch split, sampling request. - Manage the GMP activities (visual inspection & repackaging) : batch record approval & review. Follow-up and support during GMP activities. - Event / deviation / complaint management : creation, criticality review, initial impact assessment, final impact assessment, investigation, CAPA, follow-up with manufacturer and affiliates, closure. - Analyse potential improvement points. - External audit : preparation and support
September 2011 --- February 2012
Within an antibiotic filling and packaging department, my main missions were: - To ensure that batch records were sent to the QA department on GMP compliance reviewing batch records of intermediates & final drug - To support the day-to-day activites in the Manufacturing team following-up deviations, change control, CAPA and failure investigations
Continuous improvement engineer
September 2008 --- August 2011
Within a new services department of food production mechanic as heat exchanger, pumps or valves, I was in charge of the implementation of a lean improvement way of work and proposal of improvement actions : - Visual management: dashboard implemented - IT improvement e.g. creation of a new services database with services follow-up, new planning tool, receiving form and traceability sheet - 18 % of production cost reduction - Team managed within a services department and within customer’s sites
July 2003 --- October 2009
Part time and student work (week-ends and school holidays) into the distribution center of Intermarché, I was in charge of the : - picking of cold products. - picking of ambient products. - products paletization. - trucks loading.
Assembly Line Worker
June 2008 --- August 2008
Working for 3 month in the night shift within assembly department for medical devices (spray devices). - Line supply for packaging article. - Waste evacuation. - Sampling management. - Defects resolution.
May 2008 --- May 2008
1 month working for maternity leave replacement within the H5N1 flu production. - Mirage of good eggs insertion. - Allantoic fluid recolt. - Cleaning of production area.
Storekeeper & Operator
October 2007 --- April 2008
- Operator into the secondary packaging line for Fluocaril products. - Storekeeper for repackaging/labelling/relabelling areas. - Storekeeper for safety individual protection.
September 2007 --- October 2007
Operator and supplier within the glucose pockets production line.
Industrial mechanical and production engineer in Industrial Engineering from Institut Supérieur d'Etudes Logistiques (ISEL) (Le Havre - France) in 2011
Higher national diploma in IT technology in Industrial software development from High School "La Chataigneraie" (Rouen - France) in 2007