07 sep
|
Teva Pharmaceuticals
|
Buenos Aires
07 sep
Teva Pharmaceuticals
Buenos Aires
Responsibilities
- Lead and manage the site’s internal, external, and supplier audit programs, ensuring compliance with GMP regulations, corporate quality standards, and applicable health authority requirements.
- Develop, coordinate, and monitor the annual audit plan, including the organization of cross‑functional audit teams and follow‑up of corrective and preventive actions (CAPAs).
- Drive continuous improvement initiatives by assessing compliance with cGMP requirements, identifying risks and improvement opportunities, and partnering with functional teams to implement corrective actions.
- Ensure audit readiness across the site by maintaining effective audit systems, procedures, and inspection preparedness programs.
- Conduct supplier and third‑party audits as part of qualification and approval processes, ensuring vendors meet GMP requirements, quality agreements, and company expectations.
- Prepare, maintain, and update audit‑related procedures in alignment with corporate quality policies and general regulatory requirements.
- Support Regulatory Affairs and regional quality teams by providing audit documentation, supplier compliance data, and quality‑related information for product registrations and regulatory requests.
- Monitor and report quality compliance metrics and KPIs while supporting a culture of quality, compliance, and continuous improvement throughout the organization.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Engineering, or another relevant scientific or technical discipline.
- 3‑5 years of experience in the pharmaceutical industry or other regulated manufacturing environments.
- Experience in Quality Assurance, Quality Control, Manufacturing, or Quality Systems, including process controls and documentation management.
- Strong knowledge of GMP/cGMP requirements and pharmaceutical quality systems.
- Understanding of pharmaceutical regulations and health authority requirements, including ANMAT and international regula
📌 Quality Assurance Auditor (Buenos Aires)
🏢 Teva Pharmaceuticals
📍 Buenos Aires