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Senior Quality Engineer

 

Your role:

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

 

HR: 95777

Funcational Area: Quality

 

Job Requisition ID:  210004
Location:  Wuxi
Career Level:  E - Professional (10+ years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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