Senior CSV Specialist – Pharma/CRO (GxP)

Cohortias - The CRO of Latin America; Ciudad de México; Presencial; MXN 600.000 - 1.200.000; Jornada completa

Descripción de la vacante

Cohortias - The CRO of Latin America is seeking a Computerized System Validation Specialist (CSVS) to establish, implement, and maintain our validation framework across GxP-regulated systems. The role emphasizes both governance and hands-on validation work within a lean CRO setting.

You will own validation lifecycle activities, ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines, and data integrity principles, and collaborate with global stakeholders and auditors.

Formación

• 5–7 years of QA or CSV in Pharma/Biotech/Medical Device/CRO industries.
• Experience in mid-sized or CRO environments with governance and execution.
• At least 3 years authoring CSV protocols and IT vendor evaluations.
• Bachelor's degree in Life Sciences, Pharmacy, CS or related field.
• Advanced English for global stakeholder and audit interactions.

Responsabilidades

• Define, implement, and maintain SOPs, work instructions, and validation strategies for all computerized systems across their lifecycle.
• Plan, author, and execute risk-based validation deliverables and CSA protocols for software, cloud, and eClinical platforms.
• Perform compliance gap analyses and quality risk assessments to align with 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA++.
• Oversee technology service providers, SaaS vendors, and IT infrastructure partners with QA agreements, SLAs, and change controls.
• Coordinate RCA, deviations, CAPA plans, and BCP/DR for critical tech platforms.
• Act as SME for computerized systems and data integrity during audits and inspections.

Conocimientos

QA in pharma

Execution mindset

CSV protocol authoring

English proficiency

Educación

Bachelor’s in Life Sciences

Bachelor’s in Pharmacy

Bachelor’s in Computer Science

Bachelor’s in Software Engineering

Herramientas

EDC systems

eTMF systems

CTMS

RTSM/IWRS

Descripción del empleo

Cohortias - The CRO of Latin America is seeking a Computerized System Validation Specialist (CSVS) to establish, implement, and maintain our validation framework across GxP-regulated systems. The role emphasizes both governance and hands-on validation work within a lean CRO setting.

You will own validation lifecycle activities, ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, ICH guidelines, and data integrity principles, and collaborate with global stakeholders and auditors.