Working in Pharmaceutical environment since 2009, I currently work at Teelia as Information Solution Expert. In this position, I worked for Sanofi during 3 years as Validation lead for XEVMPD and started the transition to IDMP.
I have strong knowledge in:
- Regulation: Annex 11 of GMP Eu, 21 CFR Part 11, GAMP 5, Article 57, HL7 Standards,
- Regulatory Databases and related Document Management Tools: Register, AgXChange RSM, Liquent InSight, Veeva vault, RWS
- Validation deliverables: Validation plan, User requirements, Risk analysis, Qualification Protocols, Qualification report, Validation tests, Tracability Matrix, Migration specification, Mapping rules
- Operational Support
Mes compétences :
Pharmaceutical industry
Annexe 11 des GMP Eu
21 CFR part 11
ISO IDMP Standards
XEVMPD : Article 57(2)
Norme ISO 9001