Daniel Roque Email & Phone Number

For over 11 years, I am the Quality Assurance Manager of Norchim, a company involved in the production under GMP conditions (EU GMP Part II and ICH Q7) of sophisticated APIs for the pharmaceutical industry.In this highly regulated environment, I have succeeded in implementing and maintaining a quality system regularly approved by our customers and authorities (ANSM in France, FDA in the US and PMDA in Japan).I am responsible for the writing and update of quality-related documents (SOPs, protocols and reports), the management of quality issues (deviations, change control, OOS, CAPAs and complaints), equipment qualifications, cleaning validations, GMP trainings, review of batch records and release of APIs. I am also in charge of the selection of our contract manufacturers, including laboratories (GMP audits and technical agreements).Regarding the regulatory aspect, I write and update the regulatory dossiers (sections 2.3.S. and 3.2.S. of ASMF) related to the synthesis of our APIs.

Listed skills include Pharmaceutical Industry, Microsoft Office, Gmp, Microsoft Excel, and 14 others.