Discovery

Development

Testing

Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Antibody Drug Conjugates

Technologies & Platforms

Responsibilities

  • Obey the company regulations;
  • Be responsible for drafting company’s Validation Master Plan, Annual Re-Validation Plan and Annual Validation Summary Report;
  • Be responsible for drafting the procedure of validation management and relevant Sop;
  • Be responsible for the reviewing and approving of validation protocol and validation report;
  • Be responsible for the reviewing deviation and change from validation perspective
  • Be responsible for construction,maintenance and management of Validation Group; Tracking the executions of plan in valdation group.
  • Participate in internal and external audit;
  • Attend the company new project and reconstruction project and coordinate the the validation execution;
  • Finish the other jobs assigned by supervisor.

 

Basic Qualifications:

  • With the education background of medicine or relevant major of bachelor or above, with more than 5-8 years related working experience, familiar with the GMP/cGMP/EU GMP regulations;
  • Pass the all examinations before onto job(healthy situation , training);
  • Familiar with the usage of statistical software;
  • With good English spoken and writing ability.

Primary Location: China – Shanghai

To apply please send your application to HR_Biologics@wuxiapptec.com

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