Freelancer profile translated to English.
Back to original languageAbout Coumba
With 10 years of experience in qualification and validation, I am available for commissioning projects, automated equipment qualification, manufacturing process validation, and cleaning validation. Remote work desired. Occasional travel.
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km)
Experience
- COOPERHead of Metrology Qualification ValidationPHARMACEUTICALS INDUSTRYAugust 2023 - Today (2 years and 10 months)Team of 5 peopleDevelopment of the Qualification Validation plan for the 3 industrial sitesDefinition of prioritiesDefinition of qualification and validation strategiesIndustrial transferCleaning validationProcess validationIndustrial equipment qualification
- COOPERMetrology Qualification Validation EngineerOctober 2017 - Today (8 years and 8 months)• Preparation and writing of validation and qualification files and associated protocols/reports• Monitoring and Execution of qualification and validation tests• Handling of industrial transfers for products in development or in transfer• Execution of pilot and industrial batches• Risk analyses• Organization of Metrology activities and management of service providers• Project management
- DELPHARMMetrology Qualification Validation SupervisorJune 2017 - September 2017 (3 months)• Management of the Qualification department• Planning and budget management• Definition of qualification and requalification strategy• Writing of protocols and reports• Test execution• Non-conformity management
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Education
- Diplôme d'Ingénieur Option Ingénierie et Sciences Pour le VivantTélécom Physique2015Diplôme d'Ingénieur Option Ingénierie et Sciences Pour le Vivant