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Senior Quality Engineer
A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
1.Support the Mobius Single Use Quality Operation
--Ensure the Single Use operation complying with the related procedures and to identify the risk for the process.
--Handle the investigation and CAPA for the nonconformance during production and record them in Trackwise.
-- Issue and quality review the batch record for single use products.
--Online monitor the operation process as needed.
-- Support the customer audit program as needed.
--Monitor the training program as needed.
2. Lead/coordinate the QIPs (Quality Improvement Program) in Wuxi site
--Lead/coordinate the quality risk register in Wuxi site. Train the risk register as needed.
--Develop the QIPs to mitigate high risks. Train the QIP tools as needed.
--Lead/coordinate the QIPs in Wuxi site, especially for Single Use.
--Timely update the QIP sponsors and share the QIP targets.
Who you are:
--Bachelor’s degree or above in life science or pharmaceutical or equivalent.
-- 10+ years quality or manufacturing experience in pharmaceutical, medical device, or life science industry.
--Problem solving, analytical, technical, and CAPA management skills.
--Strong communicator with ability to influence
-- Good English skills at reading, writing and comprehension.
--QIP experience a plus
--GMP knowledge a plus
--Single Use products experience a plus
--Electronic document system or SAP experience a plus
Funcational Area: Quality
What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!