22 ago
|
Pfizer
|
Buenos Aires
22 ago
Pfizer
Buenos Aires
Use Your Power for Purpose
Everything we do every day is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both versátil and innovative, always putting the customer first. Your contributions ensure that our high standards are met, fostering a culture that is both adaptable and forward-thinking. Join us in our mission to make a difference through dedication and excellence in every aspect of our work.
What You Will Achieve
In this role, you will:
- Lead and maintain the Pfizer Quality Management System (QMS) for Uruguay and Paraguay, ensuring compliance with Pfizer standards, GDP/GMP requirements, and local regulations.
- Serve as the primary SOQ representative and quality contact for local stakeholders, regulatory authorities, and external partners.
- Ensure inspection readiness and lead the preparation, coordination, and management of Health Authority inspections, Pfizer internal audits, RQA audits, and self-inspections.
- Manage quality events, including deviations,
investigations, CAPAs, product quality complaints, and Notification to Management (NtM) activities.
- Monitor quality metrics and KPIs, identify trends and risks, and drive continuous improvement initiatives.
- Perform Quality Management Reviews and ensure timely closure of quality commitments and compliance actions.
- Ensure implementation and assessment of new regulatory requirements and Pfizer quality standards applicable to Uruguay and Paraguay.
- Provide quality oversight for local vendors, warehouses, logistics service providers, distributors, and other service providers operating under SOQ responsibility.
- Support market actions, product recalls, withdrawals, shortage management, and execution of QRT-related activities.
- Oversee supplier qualification, quality agreements, vendor performance reviews, and risk-based quality assessments.
- Drive quality culture and ensure appropriate GxP t
📌 Supply Operations Quality Manager/ Market Lead Uruguay/ Paraguay (Buenos Aires)
🏢 Pfizer
📍 Buenos Aires