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Mgr,Qaulity-Regulatory Compliance

Req # JR - 025551 Location Shanghai, Shanghai Municipality, China Job Category Quality Control Date posted 08/11/2020

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Essential Duties and Responsibilities

Product Post-marketing Management

Field Action (called as recall in below) handling.

  • Receives recall decision from AP, determine if China is impacted or not with the support from sub entity;
  • Participate in China Recall Strategy team;
  • Follow up issue escalation, till the decision is made;
  • Follow up recall execution and implementation until closure if China is impacted;
  • Works as subject matter expert of recall, supervise recall handling, ensure Baxter requirement and China regulations are complied

Regulatory Compliance

  • Tracking GXP/testing impacted regulatory change in China level
  • Coordinate regulatory change related implementation in China sub entities.
  • Regular communicate the
  • Manage the routine communication with authorities which include NIFDC, CHP committee, CCD and NMPA product safety supervision departments.
  • Working as Quality Representative in External Collaboration Projects.
  • Tracking the industry best practice for benchmarking.
  • China GQP owner for regulatory intelligence

Quality System Management:

  • Make sure global QMS documents implementation in greater China in a timely and compliance manner.
  • Support China manufacturing plants on some critical investigations and EU GMP guideline related gap analysis and mitigation action implementation as technical support.

Qualifications

  • Excellent communication skills with all relevant stakeholders for both external government agency and internal company
  • Expertise in China GMP/GSP regulations and EU GMP, ISO 13485, MDR, ect.
  • Strong teamwork spirits; Remote people management skill;
  • Able to analysis and solve problems independently and innovatively;
  • Proficiency in MS office;
  • Excellent communication skills in both written and verbal English.
  • Bachelor degree major in pharmaceuticals, chemistry or related;
  • 5 years working experience in pharmaceutical quality, 2 to 3 year in management position;
  • Experience in Drug and Medical Device Quality Management in multinational company
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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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