Freelancer profile translated to English.

Description

With 16 years of experience in Quality Assurance, Method Validation and Project Coordination in the Pharmaceutical, Biotech and Medical Device sectors, I help companies save time and secure their processes through the integration of Artificial Intelligence in document and project management.

What I offer:

Implementation of AI tools to accelerate the writing of quality documents (URS, CDC, reports, minutes).
Creation of automated templates (Word, Excel, Notion, PowerPoint) adapted to GMP / BPF / GAMP5 standards.
Training and awareness of quality / project teams on the effective use of AI.
Automation of project reporting and document tracking.
Support in the integration of AI into your workflows (without loss of regulatory compliance).

Examples of deliverables:

URS generated and structured in 2 hours instead of 2 days.
Project tracking table with automatically generated indicators.
Standardized and exportable quality check-lists for audits/inspections.
Simplified document process with integrated AI (time saving and reliability).

Why work with me?

Double competence: Quality/Projects expert + applied AI expert.
Pragmatic approach: simple, fast tools adapted to the field.
Confirmed experience with major pharmaceutical accounts.

Proposed formulas

AI discovery workshop (½ day): 500–800 €
Creation of an AI document template (ex: URS, IQ/OQ): 1 200–1 800 €
AI project support mission (1 month): 3 500–5 000 €

Result for my clients

30 to 50% time saved on document writing.
More homogeneous documents, faster to validate and revise.
Better responsiveness to audits and inspections.

Industry field of expertise

Languages

English
Native or bilingual

Workplace preferences

Remote only

Primarily works remotely

JCE BIOTECHNOLOGY
PHARMACEUTICAL BUSINESS MANAGER
January 2025 - Today (1 year and 5 months)
Vichy, France
SME specialized in the design and manufacture of isolators for pharmaceutical use (GMP / ISO)

Coordination of complex industrial projects (quotation → FAT / SAT / commissioning)
Client / BE / production / purchasing / quality interface
Writing and validation of project documents: URS, CDC, IQ, OQ, FAT, SAT, technical notes
Contribution to regulatory compliance: GMP, ISO 13485, Annex 15, GAMP 5
Monitoring of quality actions and coordination of critical points (deviations, deliverables, deadlines)
Commercial support: technical memorandum, project defenses, customer negotiation

Objective: to structure a cross-functional role without a formalized scope, set milestones and restore project coherence.
NEO2, AGAP2, Sanofi, Martin Dow, Panpharma, etc.
SENIOR QUALITY / CQV / PROJECT MANAGER CONSULTANT
January 2015 - January 2025 (10 years)
Equipment validation (HMI, packaging lines) MSD
Cleaning qualification / IPSEN, CENEXI lines
CAPA management, audits, documentation Sanofi, Panpharma
Freelance services
Le Parfait / Berlin Packaging
Operations Manager
January 2023 - January 2024 (1 year)
Nice, France
Monitoring of quality disputes and supplier coordination
Support for packaging development (cosmetics & food processing)
Cross-functional management with internal and external teams