Mes compétences :
Agroalimentaire
AMDEC
Analyse de cycle de vie
Cycle de vie
FDA
GMP
Ishikawa
Packaging
Pharmacie
Qualification
Qualité
Validation
Entreprises
International Company specialized in Medical Devices (Agap2 Consultant)
- Process Engineer
2014 - maintenantPackaging Development and Validation - International Project Team (US, UK, CH)
■ Creation of Design Requirement Specification
■ Testing of the different designs proposed by R&D
■ Site Project Management & collaboration with the Project Leader (planning, budget, meeting preparation, follow up of the project)
Equipment Validation (Drying Oven)
■ Vérification, update of the equipement (calibration, maintenance, order of new pieces, HVAC check)
■ Définition and creation of the Validation Strategy
■ Creation of the CSV Compliance Analysis and IQ Protocol
2012 - 2014Qualification/Validation
Qualification of production lines (contact lenses Ciba Vision (Novartis), inhalers for asthma (GlaxoSmithkline), distillation equipment used for the extraction of fatty acids from fish oil (KD Pharma), milk powder caps (Nestlé)):
■ Creation of the Validation Master Plan and of technical documents: User Requirement Specification, functional specification, GMP-risk analysis (FMEA) (Moderator for GMP risk analysis workshops)
■ Preparation of test protocols/reports (FAT/SAT/IQ/OQ/PQ) and performance of the tests
■ Creation and management of project schedules (Gantt Diagram)
Supplier Qualification
Qualification, in collaboration with Ciba Vision, of all the suppliers:
■ Elaboration of the global strategy of the project "Lean Validation through Supplier Qualification"
■ Audit of the suppliers, and evaluation of the GAP between the requirements of Ciba Vision and the documentation, tests and QMS of the suppliers
■ Recommandations to the suppliers and creation of the Project Execution Plan
■ Redaction of templates: Quality Assurance tests (documentation, design, electrotechnical, mechanical, software) to be performed by the suppliers
Creation of procedures and protocols
■ Redaction of Standard Operating Procedures, Validation Protocols and update of the internal procedures
Creation of a Project Management Tool (Project Manager)
■ Development of a new risk analysis method (High Level Risk Analysis) based on regulatory requirements and used to identify which parts of the machine are GMP-critical
Nestlé Suisse
- Packaging Engineer (Internship)
Marne La Vallée Cedex 22011 - 2011Life Cycle Assessment, environmental study on aluminium tubes using the software PIQET (Packaging Impact Quick Evaluation Tool)
■ Creation of a flowchart representing all the steps of the life cycle of the aluminium tubes, from the extraction of raw materials to the final disposal
■ Data collection for each step of the life cycle: communication with primary and secondary suppliers, Veolia Environment, OFEV, Coop, Migros, …
■ Use of the software to evaluate the global environmental impact of the tubes, and to make comparisons
■ Report with recommendations
■ Complementary studies: recycling inquiry, …
Support for Packaging Development Projects (primary, secondary and tertiary packaging: aluminium tubes and caps, trays, corrugated boxes)
■ Make sure the packaging items meet the requirements and specifications
■ Check mechanical resistance (ECT, BCT)
■ Organize and coordinate the pilot plant activities: filling of new packaging items (new materials, new supplier, …) and performance of shelf life analysis
■ Propose and develop, in collaboration with the suppliers, improvement projects on corrugated boxes: changing material, adding a window, …
■ Organize and coordinate on line trials
■ Coordinate shelf life analysis on packaging items
Neuhauser
- Employee in Production (Internship)
2009 - 2009Training and casual work (bread conditioning)
Charpalor
- Quality / R&D Engineer
2009 - 2009Development of new products with the competence center Agria Lorraine
■ Brainstorming and consumers inquiries, trends analysis
■ Emergence of key words and ideas
■ Proposal for new products:
- Innovative & in accordance with the company (traditional)
- Using the same raw materials and the same packaging items than the other recipes
Process standardization – stabilization of the production process in order to minimize the amount of rejected products
■ Use of the Ishikawa Diagram to list all the potential causes of the quality defect of the products
■ Select the potential causes that appear as relevant
■ Analyse and identify the responsible parameter
■ Recommendations
