31 oct
|
Transperfect
|
Buenos Aires
31 oct
Transperfect
Buenos Aires
At TransPerfect, we are looking for a detail-oriented and proactive QA Auditor to support and enhance our Integral Quality Management System (QMS), ensuring compliance with international standards, regulatory requirements, and industry best practices.
Key Responsibilities
- Conduct internal, customer, supplier, and regulatory audits.
- Coordinate customer audits, manage findings, and oversee corrective and preventive actions (CAPA).
- Support compliance with ISO 9001, ISO 17100, GxP, and other relevant standards.
- Analyze audit data, prepare trend reports, and contribute to continuous improvement initiatives.
- Collaborate with clients, auditors, and internal teams to strengthen quality processes and customer satisfaction.
What We’re Looking For
- Bachelor’s degree or equivalent.
- Excellent English communication skills, strong analytical and problem-solving abilities, and the ability to manage multiple priorities.
- Minimum 2 years of experience in the Life Sciences industry, including QA audits, clinical study documentation, and eClinical technologies.
- Experience with Quality Assurance, CAPA, change control, deviation management, and regulatory compliance.
- Knowledge of international quality standards and regulatory frameworks.
Nice to Have
- Lead Auditor certification (ISO 9001, ISO 27001, or similar).
- Experience in regulated industries, including pharmaceutical, healthcare, CRO, or medical devices.
- Knowledge of ICH E6, 21 CFR Part 11, GxP, and continuous improvement methodologies.
- Fluency in an additional language.
Submit your CV in English to apply!
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📌 Quality and Regulatory Affairs Auditor JR - BA (Buenos Aires)
🏢 Transperfect
📍 Buenos Aires