29 oct
|
Transperfect
|
Argentina
29 oct
Transperfect
Argentina
TransPerfect is looking for a Quality Assurance Auditor to join our QA team and support the continuous improvement of our General Quality Management System (QMS). In this role, you’ll help ensure compliance with international quality standards and regulatory requirements, including ISO 9001, ISO 17100, and applicable GxP regulations. You’ll play a key role in managing customer and internal audits, coordinating audit activities, investigating findings, overseeing Corrective and Preventive Actions (CAPA), and driving continuous improvement across the organization.
Key Responsibilities
• Plan, coordinate, and conduct customer, internal, and compliance audits.
• Manage audit findings, corrective actions, and follow-up activities.
• Support regulatory inspections, customer qualifications, and supplier audits.
• Analyze audit data, identify trends, and prepare reports for management.
• Collaborate with internal teams, clients, and external auditors to ensure compliance and quality excellence.
• Contribute to the development and continuous improvement of QA programs, policies, and procedures. Requirements
• Bachelor’s degree or equivalent.
• Excellent written and verbal communication skills in English.
• At least 2 years of experience in the Life Sciences industry, including QA-related audits, clinical study documentation, and eClinical technologies.
• Knowledge of ISO standards, CAPA, change control, deviation management, and regulatory compliance.
• Strong analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities and work independently and collaboratively. Nice to Have
• Lead Auditor certification in relevant ISO standards.
• Experience in regulated industries, such as pharmaceuticals, healthcare, CROs, or medical devices.
• Knowledge of GxP, ICH E6, and 21 CFR Part 11.
• Experience with Lean, Six Sigma, or additional quality standards.
• Fluency in a language other than English. ?Apply by submitting your CV in English. #Hiring #QualityAssurance #QA #Auditor #LifeSciences #QualityManagement #RegulatoryCompliance #TransPerfect
📌 QA Auditor Jr (Argentina)
🏢 Transperfect
📍 Argentina