Senior CSV Compliance Advisor — GxP & 21 CFR 11

Rhian_Convatec; Reynosa; Presencial; MXN 1,108,000 - 1,478,000; Jornada completa

Descripción de la vacante

A global medical products company located in Reynosa, Tamaulipas, is seeking an eCSV Senior Analyst to oversee projects and ensure compliance with GxP regulations. The ideal candidate will have a bachelor's degree in a related field and experience in computer systems validation within the pharmaceutical or medical device industry. Strong communication skills in English are required to collaborate effectively with quality validation teams.

Formación

• Experience in computer systems validation.
• Knowledge of industry regulations and guidelines like GxP and 21 CFR Part 11.
• Experience in pharmaceutical manufacturing or medical device industry.

Responsabilidades

• Assess new computerized systems or software for GxP impact.
• Review changes to validated computer systems and identify necessary requirements.
• Perform periodic assessments to confirm the validated status of systems.

Conocimientos

GxP knowledge

Computer systems validation

Collaboration skills

Fluency in English

Educación

Bachelor's degree in computer science, engineering, life science, or a related field

Descripción del empleo

A global medical products company located in Reynosa, Tamaulipas, is seeking an eCSV Senior Analyst to oversee projects and ensure compliance with GxP regulations. The ideal candidate will have a bachelor's degree in a related field and experience in computer systems validation within the pharmaceutical or medical device industry. Strong communication skills in English are required to collaborate effectively with quality validation teams.