Sebastien Gawlik

Evolutive documentation database for scientific and submission data:
- definition of users requests (URS for 5 departments)
- definition of technical specifications
- selection of the electronic solution
- Qualification of the configuration (risk analyses, IQ, OQ, PQ)
- Delivery of the solution
- User training and support

According with internal requirements and international references (ICH, 21 CFR Part. 11, e-CTD...)

Sector: Health and pharmaceutical

- Dosage forms: contrast media (injections) for medical imaging - X rays (iodinated drug products) et NMR (drug products containing gadolinium).
- Setting up and follow-up of studies leading to the writing of Module 3 of CTDs: study protocols for scientific data and achieving of the experiments ; development and validation of analytical methods ; stability study protocols ; support to process validation.
- Preparation of pharmaceutical dossiers: full dossiers and variations (for Europe, USA and Japan). Team work with pharmaceutical experts. Preparation and follow-up of sub-contracted analyses (invitation to tender and technical specifications).
- Teamwork for qualification of a chemical pilot plant according cGMP standards
- Leading of a team of 4 technicians, in a "project" organisation
- Used references: European and US GMP, guidelines (ICH, EMEA, FDA...), pharmacopiaes (EP, USP, JP).
- Everyday use of English langage (oral and writting)

Sector: Health and pharmaceutical

- Development and validation of analytical methods for cleaning validation in pharmaceutical manufacture (scope: manufacturing site transfer).
- Training of operators to swabbing techniques onto the equipments.
- Team work with the aim of the preparation of a guidance text of the "SFSTP".

Sector: Health and pharmaceutical