Clinical QA Specialist — Pharma/CRO

Cohortias - The CRO of Latin America; Ciudad de México; Presencial; MXN 480.000 - 720.000; Jornada completa

Descripción de la vacante

Cohortias - The CRO of Latin America is seeking a meticulous Quality Assurance Specialist to support QMS operations across clinical trials. You will oversee document control, CAPA management, and audits, ensuring ongoing compliance with GCP and regulatory standards.

In this specialist I role, you will collaborate with Clinical Operations, Regulatory, and Data Management teams to drive risk-based quality improvements and readiness for health authority inspections (COFEPRIS, FDA, EMA).

Formación

• 2+ years of experience in Clinical Quality Assurance or related roles in pharma/biotech/CRO.
• Strong knowledge of ICH-GCP guidelines and quality risk management.
• Experience with document control, CAPA tracking, deviations, and audits.
• Bachelor degree in Life Sciences or related field; advanced certification is a plus.
• Familiarity with data integrity concepts (ALCOA++), 21 CFR Part 11, and KPIs.
• Advanced English communication for global collaboration.

Responsabilidades

• QMS & Document Control: maintain SOPs, forms, and controlled documents across teams.
• CAPA & Deviation Tracking: monitor actions and root-cause analysis.
• Audit Execution & Readiness: plan, prepare, and support audits (internal, site, vendor).
• Operational GCP Advisory: provide guidance to Clinical Ops, Data Mgmt, Regulatory.
• RBQM & risk management: support quality risk assessments and trend analysis.
• Compliance Oversight: assess systems against 21 CFR Part 11 and data integrity standards.

Conocimientos

Document control

CAPA management

Audit execution

GCP knowledge

QMS operations

RBQM

Data integrity

Regulatory awareness

21 CFR Part 11

Educación

Bachelor’s degree in Life Sciences / Pharmacy / Nursing or related field

Master’s degree or RQAP-GCP certification (plus)

Herramientas

QMS software

Spreadsheets

Descripción del empleo

Cohortias - The CRO of Latin America is seeking a meticulous Quality Assurance Specialist to support QMS operations across clinical trials. You will oversee document control, CAPA management, and audits, ensuring ongoing compliance with GCP and regulatory standards.

In this specialist I role, you will collaborate with Clinical Operations, Regulatory, and Data Management teams to drive risk-based quality improvements and readiness for health authority inspections (COFEPRIS, FDA, EMA).