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Description

Hello,

I am a qualification officer and have been working in the pharmaceutical industry for 5 years.

I help industrial companies ensure the compliance, performance, and safety of their equipment.

Document writing, FAT/SAT/IQ/OQ/PQ, risk analyses, compliance.

I am a versatile, autonomous, reliable, and results-oriented person.

I intervene to strengthen your teams or manage your projects.

I am available immediately for short or long-term assignments.

Industry field of expertise

Languages

French
Native or bilingual
English
Conversational

Workplace preferences

Can work on-site

Lyon (up to 50km)

Thermofisher,
Equipment Qualification Officer
PHARMACEUTICALS INDUSTRY
September 2024 - August 2025 (11 months)
38300 Bourgoin-Jallieu, France
• HVAC System: Writing protocols and executing IQ/OQ/PQ tests
• Packaging: Writing protocols and executing IQ/OQ/PQ tests (Primary and secondary packaging lines, Noack, bagging machine, counter, capping machine)
• Tooling: Execution of punch IQ/OQ tests
• Small mixing and transfer equipment: IQ/OQ
• Granulometry: Writing protocols/reports and executing PQ tests.
• Writing CAPA and follow-up on Trackwise
Writing protocols and executing qualification tests IQ/OQ/PQ Technical Management Project Management HVAC
Sanofi,
Equipment Qualification Officer
March 2024 - September 2024 (6 months)
69250 Neuville-sur-Saône, France
• Reading P&ID
• Electrical panel: Coordination of functional analysis
• Site work monitoring EVF
• Anomaly management
Clauger,
Equipment Qualification Officer
July 2023 - March 2024 (8 months)
69530 Brignais, France
• HVAC System: Writing SAT/ITP/Self-control protocols
• Reading P&ID / SAT Plan
• Electrical panel: Writing FAT protocol/report - Execution of FAT tests
Writing ITP / Self-controls
• Equipment qualification anomaly management Project
• Premises Qualification: Writing protocol/report - Execution of IQ/OQ tests
Smoke test - Interlocking
• Qualification of Watson Marlow peristaltic pumps: Writing protocol/report - Execution of IQ/OQ tests
• Preparation of client audit documentation