YuShan Hu

Experience

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  SuZhou Chunghua Pharmaceutical Industrial Co.LTD

  Feb 2006 - Jul 2009

  QA Specialist

  Work on the in-process quality control, be in charge of double checking of active ingredient and excipients, make sure the conformation with prescription; and sampling the simi-prodcuts for physical /chemical performance testing. reviewing the production process/in-process control/finished products records, and release the finished goods according to the results of review and NC handling. supporting the validation/verification work and executing the retain samples inspection work as requirement. Show less

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  Suzhou Chunghua Pharmaceutical Industrial Co.,Ltd

  Jul 2009 - Feb 2011

  Shift Leader

  work on the routine production management in environment contolling area, arranging the daily production missions and employees distribution ; plan to apply the related materials for production process running smoothly. handling the quality devaition properly and training employees to execute operation safely. draft the related Sops for machines operation/maintenance; supporting the validation of new prodcuts process and verification of facilities cleaning/capcity.

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  Fresenius Medical Care(Jiangsu) Co., Ltd.

  Feb 2011 - May 2012

  Quality Engieer

  work on the in-process contol(IPC) for the injection molding process of components/extrusion process of tubing/ assembling process of bloodlines, draft/update the quality control plan/specification to meet the requirement of IPC/ industrial regulatory, supporting the validation work. and co-ordinate to handle the non-conform(NC) and the disposition of the semi-products/finished products affected. and supporting the new parts/process/code transition from RND study to routine prodcution periods.

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  Fresenius Medical care(Jiangsu)

  May 2012 - Dec 2013

  Validation engineer

  work on the process validation of injection molding process and extrusion process of tubing systems, and the verfication of auto-assembly machines/packaging machines. draft the protocols, execute the process inspection and functional testing/deviation notes/analysis/evaluation, finsihed the validation/verification reports finally.

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  Fresenius Medical care（Jiangsu）

  Dec 2013 - now

  QE Engineer

  1. complaints receives, commnunicating, inspection/analysis, samples handling, prepare the investigation reports and feedback;2. call the related team(PRD/QM/RND/SCM/...) together to review the quailty trend of post-marketing goods; 3. Co-ordinating the on-site visiting of end customer(hospitals/dealers) for some typical complaints;4. Identify and Submit the suspect ADE to the regulatory authority ;