vigentes (ANMAT, PIC/S, EU GMP, FDA). Mantener el estado validado de equipos y procesos productivos. Coordinar actividades...
vigentes (ANMAT, PIC/S, EU GMP, FDA). Mantener el estado validado de equipos y procesos productivos. Coordinar actividades...
: Normas GMP (ANMAT/FDA/EMA), Farmacopeas e ISO (14644/17025). Gestión: Procesos de validación, calificación de equipos...: gmp anmat fda ema biotecnologia biologia vacunas anticuerpos downstream purificacion tff api Nosotros...
, Biotecnología industrial y producción de vacunas/anticuerpos Calidad y Normativa: Normas GMP (ANMAT/FDA/EMA), Farmacopeas e ISO...
of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR...
% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial...
of the job. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95...
. - Core Knowledge: Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations...
sensitive matters. - Expertise in management of deviations and Non-Conformities (NCs);RCA and CAPA process based on FDA, EMA...
Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products...