and PLM systems (i.E. Windchill, ADAPTIV, etc.) in a regulated industry is highly desirable.- GMP/ ISO knowledge preferred...
;asà como apoyar en los programas encaminados a mejorar los procesos y sistemas actuales como: GMP, ISO 13485, etc. **ROLES Y...
for registered products.- Coordinate product renewals on due date.- Request and organize all GMP Inspections at international...
Participate in the Validation of Processes and/or Raw Material. (QS 9000 AND GMP's (Good Manufacturing Practices)- QSR's -Quality...
and subcontractors.- Develop and maintain an effective Pharmaceutical Quality Management System (QMS) to align with EU GMP, GDP, GVP... organizations.- Develop and maintain a comprehensive understanding of EU GMP and GDP regulatory requirements.- Manage key quality...
or other regulated industry is required. Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485...
of the quality system to meet with ISO 13485:2016of the Quality System Regulation (QSR)/Good Manufacturing Practices (GMP...
.Conocimientos y experiência trabajando con normativa GMP.Valorable conocimientos y experiência trabajando con normativa FDA...
de Cumplimiento (Compliance). Cumplimiento con las Buenas Prácticas de Manufactura (GMP's) levantando observaciones y comunicándolas...
practices (GMP) and quality standards are met.- Evaluates suppliers' internal functions to assess their overall performance...