Freelancer profile translated to English.

Description

Pharmaceutical Quality Assurance and Control Consultant, with 15 years of field experience (Takeda, Johnson & Johnson, Celgene BMS, Ferring, and Novartis).

I specialize in: Qualification Validation, analytical methods (HPLC, GC...), CAPA and deviation management, quality audits, SOP writing, team management in GMP and ISO 13485 environments. Available immediately for short or long-term assignments, on-site or remote, in France, Switzerland, Morocco, and internationally.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent
German
Conversational
Arabic
Conversational

Workplace preferences

Can work on-site

Nyon (up to 50km)

Takeda
Scientist
PHARMACEUTICALS INDUSTRY
February 2023 - April 2023 (2 months)
Neuchatel, Switzerland
• ▪ HPLC method validation and revalidation in GMP/ICH environment
• ▪ Technical protocol writing
HPLC Validation GMP LIMS ICH
Johnson & Johnson
Senior QA Technician & Team Leader
January 2021 - January 2022 (1 year)
Neuchatel, Switzerland
• ▪ Pharma & Medical Device Quality Management — GMP / ISO 13485
• ▪ Supervision of 25 operators, planning
• ▪ CAPA and deviation management
Ferring Pharmaceuticals
Quality Control Specialist
PHARMACEUTICALS INDUSTRY
January 2016 - January 2020 (4 years)
Saint-Prex, VD, Switzerland
Annual Product Review
Update the pharmacopeia (ICH) verification of method (monographs)
Training
GC / HPLC
Control of medical devices and packaging
Sampling raw material and medical devices
Sampling and control of utilities
Stabilities
Logging in the Lims
Completion and modification of procedures (SOP) and standard work
Qualification and Validation of spectrophotometer Cobalt
Project of vision system EyeC
Identification with IR
Identification with solution
Disaggregation / Desiccation / Spectrophotometry / Colorimetry / Solubility /
Viscosity / LOD
Karl Fischer method
QR and CAPA management
Expert for audits