Quality Assurance Officer
New A Innovation Limited
New Zealand
32d ago

The Job :

  • Assist in developing and maintaining the Quality Assurance System in New Zealand Manufacturing Site according to the GMP and RMP requirements
  • Review qualification and validation documents and the related technical documents
  • Report any urgent quality issues to management in a timely manner
  • Establish and implement an effective Quality Management System in accordance with GMP Principles and RMP requirements
  • Draft, review and distribute quality documentation such as Standard Operation Procedures (SOP) and other quality system documents such as specifications, supplier evaluation etc.
  • Assist in preparing Management Review Reports, Product Quality Review (PQR) Reports, Quality Manual, Validation Master Plan and Site Master File.
  • Ensure corporate quality policies and standards are adhered to by all staff at New Zealand Manufacturing Site
  • Maintain quality documentation and retain records appropriately
  • Provide training to staff to enhance understanding of GMP as directed
  • Liaise with authorities concerning various licenses and certificates such as RMP
  • Participate in self inspections and external audits
  • Participate in quality risk management, change control, deviations CAPA, OOS investigations and batch record review
  • Perform Line Clearance Check
  • Other projects as assigned by the Quality Assurance Manager, to improve Quality System within the company and the site
  • The Person :

  • University graduate or above in pharmaceutical science, quality assurance, chemical and biological disciplines
  • 1-3 year of QA experience in quality assurance field in GMP pharmaceutical manufacturing industry
  • Knowledge in global pharmaceutical regulations and standards
  • Good interpersonal skills
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