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QA for QC Engineer/Senior Engineer

QA for QC Engineer/Senior Engineer

Job Responsibility:

  • Assist QA for QC Lead to support the establishment of quality management system of QC department and the future oversight of operation/maintenance
  • Participate in the investigation of lab deviation/OOS/OOT/MDD etc., and support review the investigation report;
  • Support the qualification activities of instrument/equipment in QC area, such as qualification protocol review;
  • Support the analytical method transfer, qualification/verification and validation etc. relevant documents review;
  • Support all QC relevant document/record review relevant with Client project;
  • Support the analysis report and original data/record review of material/product release;
  • Support the answering and audit response to client audit/regulatory inspection in QC area, the development of CAPA plan and oversight the implementation and effectiveness evaluation;
  • Support the client IND documents submission, responsible for the data/information review input by QC.
  • Other works assigned by the QA head

Job Requirements:

  • Education background: Bachelor degree or above, major in pharmacy, chemistry, pharmaceutical engineering or related
  • At least 4 years working experience in QA department of pharmaceutical company, experience in on-site management of QA for QC is preferred;
  • Good capability of Microsoft Excel, PPT, Word, etc.
  • Good organization, coordination, communication and planning skills, good reading and writing skills in English, good oral English is preferred;
  • Strong sense of teamwork, proactive and enthusiastic, able to work under great pressure and have a high sense of responsibility.
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