Global Quality & Regulatory Auditor

TransPerfect Inc; Buenos Aires; Híbrido; ARS 90.547.000 - 135.820.000; Jornada completa

Descripción de la vacante

TransPerfect Inc. seeks a Quality Assurance Auditor to join its Global Quality Management System (QMS), ensuring compliance with ISO 9001, ISO 17100 and related regulations.

You will help develop, implement, and continually improve QA programs, policies and procedures across audits and CAPA activities. The role requires strong English communication, a bachelor’s degree, and Life Sciences QA audit experience, including CAPA, change control, deviation management and regulatory compliance.

Formación

• Bachelor's degree or equivalent required.
• Experience with ISO 9001, ISO 17100 (EN 15038) and/or ISO 27001 and/or other standards and regulations.
• Experience overseeing sponsor audits, internal and/or regulatory inspections.
• Proven experience in QA, CAPA, change control, deviation management and regulatory compliance.
• Minimum two years in Life Sciences QA including audits and regulatory documentation.

Responsabilidades

• Participate in development and execution of audit programs and schedules.
• Perform auditing activities in line with ISO 9001, ISO 17100, GxP and other standards.
• Host and coordinate customer audits and qualification activities, including communications and outcomes.
• Prepare for and host customer audits, allocating internal resources.
• Manage and close audit findings and corrective actions within timeframes.
• Build relationships with client auditors, reps, and internal stakeholders.
• Assist with RFI/RFP coordination and related tasks.
• Conduct QA internal and ad-hoc audits; support regulatory inspections as needed.
• Maintain QA databases and auditing trackers; analyze findings.
• Prepare periodic trend reports for management and support management reviews.
• Contribute to continuous improvement of QA procedures and Total Quality Management.

Conocimientos

English communication

Bachelor's degree

ISO 9001

ISO 17100

QA audits

CAPA

Regulatory compliance

Life sciences QA

Audit coordination

GxP knowledge

Educación

Bachelor's degree or equivalent

Herramientas

Microsoft Office

Descripción del empleo

TransPerfect Inc. seeks a Quality Assurance Auditor to join its Global Quality Management System (QMS), ensuring compliance with ISO 9001, ISO 17100 and related regulations.

You will help develop, implement, and continually improve QA programs, policies and procedures across audits and CAPA activities. The role requires strong English communication, a bachelor’s degree, and Life Sciences QA audit experience, including CAPA, change control, deviation management and regulatory compliance.