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Regulatory Compliance Officer

1 week ago


Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Job Overview:
Fujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance-Compliance Specialist II-Audit and Inspection to join our team. This role will support all associated responsibilities in compliance with quality policies and site SOPs to ensure regulatory compliance.

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About the Role:
This position will work collaboratively with site management to instill a 'Quality Culture' by coaching in the application of GMP Principles. The ideal candidate will have excellent written and oral communication skills, as well as excellent organizational, analytical, data review, and report writing skills.

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Key Accountabilities:

  • \
  • Provide QA support to the organization during client audits and regulatory inspections.\
  • Work with Quality management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.\
  • Ensure no overdue training or site actions.\
  • Support other QA teams and other functions in completion of site actions.\\/ul>\

Why Join Us:
Fujifilm Diosynth Biotechnologies is a global leader in the development and manufacturing of biopharmaceuticals. We offer a dynamic and supportive work environment, with opportunities for professional growth and development.