Hybrid CSV Specialist: GxP Compliance & Validation Expert

Cohortias - The Cro Of Latin America; Xico; Híbrido; MXN 850.000 - 1.100.000; Jornada completa

Descripción de la vacante

Cohortias is seeking a Computerized System Validation Specialist (CSVS) to establish, implement, and maintain governance, compliance, and validation frameworks across our IT landscape in Mexico City. The role is specialist-level and autonomous, focusing on GxP-regulated and eClinical systems with strong technical rigor.

You will own validation lifecycle activities end-to-end, drive risk-based testing, and support sponsor audits and regulatory inspections, ensuring data integrity and compliance

Formación

• 5–7 years QA or CSV experience in Pharma/Biotech/Medical Device or CRO sectors.
• 3+ years authoring CSV protocols and leading GxP assessments.
• Bachelor’s degree in Life Sciences, Pharmacy, CS or related field.
• Advanced English for global stakeholder interactions.

Responsabilidades

• Define, implement, and maintain SOPs and validation strategies across systems.
• Plan, author, and execute risk-based validation deliverables (IQ/OQ/PQ) and CSA protocols.
• Perform regulatory and quality risk management per ICH Q9, 21 CFR Part 11, EU Annex 11.
• Oversee vendor qualification, SLAs, audit trails, and change controls.
• Coordinate RCA, deviations, CAPAs, and BCP/DR for critical tech platforms.
• Serve as SME during sponsor audits and regulatory inspections.

Conocimientos

Execution & Ownership Mindset

Quality Assurance

CSV Experience

Educación

Bachelor's degree in Life Sciences

Descripción del empleo

Cohortias is seeking a Computerized System Validation Specialist (CSVS) to establish, implement, and maintain governance, compliance, and validation frameworks across our IT landscape in Mexico City. The role is specialist-level and autonomous, focusing on GxP-regulated and eClinical systems with strong technical rigor.

You will own validation lifecycle activities end-to-end, drive risk-based testing, and support sponsor audits and regulatory inspections, ensuring data integrity and compliance