Quality Assurance Expert
4 days ago
At Pfizer, S.A. de C.V., we innovate every day to make the world a healthier place. We strive to bring life-changing treatments to patients globally.
As a key member of our Quality Assurance and Control team, you will be responsible for ensuring compliance with established standards and agency guidelines.
You will collaborate with cross-functional teams, including regulatory strategists, to review and assess changes affecting our third-party manufacturing operations.
Your expertise will be invaluable in identifying potential regulatory impacts and implementing corrective actions.
Key Responsibilities
- Support post-approval changes, initial registrations, and/or renewals.
- Liaise between CMOs, VSOTs, and other stakeholders to ensure seamless communication.
- Initiate QTS records, post-approval change records, and regulatory change control for third-party manufacturing operations.
- Coordinate document collection and maintain accurate records.
- Monitor regulatory submission status and escalate issues promptly.
Requirements
- Bachelor's degree and 2+ years of relevant experience.
- Excellent leadership, presentation, and oral/written communication skills.
- Able to build strong relationships with leaders and cross-functional teams.
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