Barthélémy Cayeux

Interventions for Quality Assurance projects in the health and agri-food industries

Equipment qualifications, cleaning validations in agri-food enzyme production workshops - Drafting of documents: Risk Analysis, Validation Master Plan - Documentary review: User Requirement Specification, qualification and validation protocols - Quality Assurance support and monitoring for qualification and validation tests

Management of the control of particulate contamination in clean and dry rooms for the production of batteries for electric cars Layout of Material AirLocks and equipment and Personal AirLocks Training in gowning and ungowning in personal airlocks Determination of the sampling points Animation of weekly meetings to review the results of particulate controls Reviews of quality procedures: reaction plans, particulate control with particle traps, volume particle counting

Implementation of Good Manufacturing Practices in the Specialty Amino Acids (glutamates, aspartic acid, and glutamic acid) production facilities Drafting quality procedures (equipment qualification, cleaning validation, good documentation practices) Determining the scope of equipment, cleaning procedures, and parameters to be qualified and validated Drafting the Validation Master Plan, Risk Analyses, protocols, and test sheets Equipment qualification, cleaning validation GMP staff training Conducting internal audits in production facilities (ISO 9001, 14001, 45001, and 50001 standards)

Qualification of automated equipment : bagging machine, unblisterring machine, palettiser, capsule filler Validation of manual cleaning methods for sampling rods, compacting press, grinder, capsule filler

Qualification and Validation Engineer - Installation Qualification and Operationnal Qualification of MAL Dry Fog (bio decontamination premises) - Conception of validation documentation (periodic reviews, risk assessments) for sterilisation autoclaves, washing machines and pure steam. - Conception of validation documentation: periodic reviews, risk assessments Manual cleaning, CIP and SIP of permanent and mobile tanks, fluid networks (WFI, LPW, CAP, pure steam), decontamination station, dry-fog sanitisation, cold rooms etc. - Implementation of quality improvements in cleaning practices of production materials Audits of the cleaning practices (manual in sinks, washing machine, CIP) Establishing with the Support service of the cleaning practices improvements Quality Engineer, metrology laboratory - Deviations management for the calibrations of measuring instruments, in SAP database - Descriptions of the gaps (calibration drifts, expiry of calibration delays, absence of « as found » values etc.), root causes analysis, action plans

Assignments in pharmaceutical industries : Lilly, Lonza, GSK Vaccines and UCB

Validation of a new unit of powder micronisation : Conception of the cleaning procedure and of the process and cleaning validation protocols -Cleaning validation : detection test with riboflavin, Total Organic Carbon (TOC), conductivity test, microbiological analysis - Process Validation : loss rates of product, control of process parameters, quality control of product

Implementation of procedures regarding the monitoring in Controlled Atmosphere Areas according to the FDA rules : bacteriological controls (water, air, surfaces), particular counting, entry/exit rules, cleaning. Local specifications writing, implementation of procedures in the packaging rooms, bacteriological controls and particular counting monitoring. According to standards: ISO 14698 Cleanrooms and associated controlled environments - Bio contamination control ISO 14644 Cleanrooms and associated controlled environments – Particular counting

Assignments in pharmaceutical and chemical industries - Oril Industrie, chemical industry of the Servier laboratories Installation Qualifications of reactors, dryers filters and solvents networks - Stallergenes, anti-allergenic medicines manufacturing Installation Qualifications and Operational Qualifications of a compressed air network - Servier laboratories, tablets manufacturing units Installation Qualifications and Operational Qualifications and Performance Qualifications of instruments (labeller, dryer, tablets tester) and packaging format

Writting qualification protocols(IQ, OQ and PQ) in French and English for equipment and softwares used in microbiological analysis laboratories - Qualification protocols of automated systems : diluter, autoprocessors of culture media, sterilizer, autoclave, peristaltic pump etc. - Qualification protocols of computerized systems : software used for the monitoring of temperature in laboratory, software used for the management of microbiological analysis

ACM PHARMA – Microbiological controls of cosmetic and pharmaceutical products SILLIKER – Microbiological analysis of food products SOURCES 77 – Microbiological controls of spring water Chantereine - Collect the samples - Filtering the water samples and bacterial culturee - Dilution of food, pharma and cosmetic products - Sowing on culture media - Total flora counting - Research of specific germs (Listeria, Salmonelles, Pseudomonas, E. Coli etc.)