
Quality Assurance Lead
22 hours ago
We are seeking a highly skilled Senior QA Professional to play a key role in delivering high-quality products.
Main Responsibilities:- Ensure that batch disposition activities align with client standards and best practices.
- Manage and drive quality records to closure, ensuring timely resolution of issues.
- Initiate quality records for supplier-related changes, promoting continuous improvement.
- Collaborate with the complaints team to address reviews and resolve customer concerns.
- Prepare, review, and approve SOPs and GMP documentation, ensuring compliance with regulatory requirements.
- Contribute to operational and quality improvement initiatives, driving excellence in our processes.
- Bachelor's degree in a relevant scientific or engineering field.
- Minimum 4+ years of experience in QA, cGMP manufacturing environment, with direct involvement in batch release activities.
- Strong working knowledge of SAP and other relevant systems.
- Investigations, project management, and trending/analysis experience, with a focus on quality and process improvement.
- Excellent analytical, troubleshooting, and communication skills, with the ability to influence others positively.
This role requires effective collaboration with global teams, prioritization of tasks, and influencing others positively to drive business success.
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Senior Quality Assurance Manager
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Quality Compliance Senior Manager
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Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland Amgen SA Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...