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 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 EngineerMay 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 ConsultantApril 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 AssociateJune 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
Production EngineerSeptember 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 engineerSeptember 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
Order PickerJuly 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.
Production OperatorMay 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 & OperatorOctober 2007 --- April 2008
- operator into the secondary Packaging line for fluocaril products. - storekeeper for repackaging/labelling/relabelling areas. - storekeeper for safety individual protection.
OperatorSeptember 2007 --- October 2007
operator and supplier within the glucose pockets production line.
LinkedIn Assessment :
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
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