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Supervisor ~ Manager, FUME&DI

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:

 

  • Establish lifecycle management of DI for GxP process:
  • Security management
  • Backup, restore and archive management
  • Business continuity management
  • Computerized system validation (CSV) management
  • Periodic review of computerized system management
  • Audit trail management
  • Configuration management
  • Data migration management
  • Computerized system supplier management
  • Computerized system retirement management
  • Ensure all the GxP processes/activities meet the requirements of regulations (U.S. FDA 21 CFR Part 11, EU GMP Annex 11, NMPA), guidance and the best practice of industry.
  • Perform quality oversight on process/system of GxP area regarding DI.
  • Create and maintain computerized system inventory.
  • Perform internal DI audit and resolve any DI problem with the other functions.
  • Review SOP/Instruction from business department regarding DI.
  • Provide DI requirements and training for people who are involved in GxP activities.
  • Provide quality oversight for computerized system supplier and CSV supplier.
  • Lead GMP oversight for FUME (Facility / Utility / Maintenance / Equipment) and CS (Computerized System) according to the cGMP and internal guidance.
  • Review qualification & validation document, alarm and maintenance record, engineering management review, etc.
  • Approve deviation / change control / CAPA / qualification / validation documents and related documents of FUME and CS.

 

Requirements:

 

  • University graduate, major in computer science, automation, biotechnology, pharmacology.
  • Minimum 5 years of experience in the GMP area, biopharma experience is preferred.
  • Familiar with the pharmaceutical industry regulations, such as U.S. FDA 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP5.
  • 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