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GE HealthCare QA Leader - PET Mexico, Mexico City 641473718
15.12.2024
Essential Responsibilities
- Managing the quality relationship through set up and continuous oversight of multiple third party manufacturing sites to achieve consistent product quality and compliance to applicable regulatory requirements
- Conducting reviews, performing audits, clearly documenting findings and identifying risk across the PET Global Supply Chain
- Clearly communicating audit results and recommendations
- Providing follow up activities to internal and external audits including: identifying root cause, assessing risk and providing direction on potential resolution.
- Supporting routine internal QA operating mechanisms to ensure compliance and continuous improvement of the supply chain and quality management system
- Supporting activities related to product registrations and regulatory processes
- Representing QA on technology transfer and product / process improvement projects
Qualifications /Requirements
Bachelor's degree in a Scientific, Engineering, Computer Science, core Life Science discipline, or a combination of training and experience demonstrating the equivalent
- 3+ years of Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry;
- Supervisory/managementexperience
Desired Characteristics
- Certified Auditor or Lead Auditor
- Experience working in remote teams and with people in different countries
- Knowledge and experience of the manufacture of radiopharmaceuticals and /or medical devices
- Experience hosting and /or responding to regulatory GMP or ISO inspections
- Strong track record of identifying and fixing compliance issues
- Strong process improvement mindset, passion for quality
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
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