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Supervisor ~ Manager, DS System Validation

Department: Quality
Location: Suzhou

April 12, 2021

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The Company

Harbour BioMed is a Global Biotherapeutics Company primarily focused on inventing, developing, manufacturing and commercializing novel therapeutics for the treatment of serious medical conditions in oncology, and immunology. HBM has labs and business operations in Cambridge in the US, Rotterdam in Netherlands and Shanghai and Suzhou, China. We aim to help people with complex and debilitating conditions by identifying unmet medical and patient needs and driving strong science supported by our two patented transgenic mouse platforms for generating fully human monoclonal antibodies. Our approach is shaped by our experienced team’s capability in delivering highly specialized treatments and forging close relationships with physicians and patients to understand the NextGen treatments that will provide hope to patients and their families around the world.

 

Responsibilities:

 

  • Responsible for qualifications of DS equipment and related system.
  • Create, review, and execute qualification protocol and procedure.
  • Create and review qualification summary reports.
  • Review and approve qualification protocol and report published by supplier.
  • Support in SOP developing of DS equipment.
  • Maintain the qualified state of DS equipment during the lifecycle.
  • Responsible for handling deviation, change control, CAPA regarding qualifications of DS equipment.
  • Support GMP audit/inspection regarding DS equipment qualification.

 

Requirements:

 

  • University graduate, major in biology, chemistry, pharmacy, machinery, automation.
  • Minimum 5 years of experience in the Quality area, biopharma experience is preferred.
  • Familiar with the pharmaceutical industry regulations, such as NMPA/EMA/FDA GMP/ISPE Guideline.
  • Familiar with basic statistics knowledge & tools.
  • Excellent organizational, communication, and interpersonal skills.
  • Good team player, strong sense of responsibility and good flexibility under certain work pressure.
  • Good English in listening, speaking, reading and writing.
  • Good computer and software skills.

 

 

If you are interested in applying for this position, please contact us at HBM.HR@harbourbiomed.com

Contact us:

If you are interested in applying for this position, please contact us at

HBM.HR@harbourbiomed.com