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Supervisor ~ Associate Manager, Facility &Utility 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 developing and maintaining lifecycle management of facility and utility qualification.
  • Responsible for performing facility, utility qualification either independently or corporate with external personnel.
  • Responsible for developing qualification protocol and report for facility and utility.
  • Responsible for managing in house validation instrument (including maintenance, calibration).
  • Responsible for maintaining on-site validation labels related to qualification to an up-date-manner.
  • Responsible for maintaining site validation master plan, and individual validation plan.
  • Responsible for management of deviation, change control and CAPA during validation phase.
  • Support internal/external audit and GMP inspection.
  • Perform other duties delegated by immediate supervisor.
  • Cooperation with other team member regarding qualification/validation activities.

 

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.
  • 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