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Job details

Location
Macquarie Park
Salary
Attractive salary package
Job Type
Full Time
Ref
37566
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61 2 8877 8718
Posted
over 2 years ago

Job details

Location
Macquarie Park
Salary
Attractive salary package
Job Type
Full Time
Ref
37566
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61 2 8877 8718
Posted
over 2 years ago

Benefits

  • Work for a world leading pharmaceutical company
  • Gainglobal and regional exposure
  • Excellent Awards Program with recognition for contributions
  • Attractive salary package with excellent employee benefits
  • Structured training and development with excellent mentorship
  • Supportive and positive working environment
  • Flexibility to WFH/office

About the company

A global pharmaceutical company. They are a trusted leader in oncology, cardiovascular, autoimmune and many more therapeutic areas and are committed to providing best products to millions of people around the world.

About the opportunity

This is a high-level opportunity with a leading pharmaceutical company. Reporting to the Senior Development QA Manager you will support clinical trials with GCP quality assurance and compliance across the ANZ product portfolio. The ideal candidate will have a comprehensive understanding of clinical operations and GCP regulations to support with deviations, non-conformances, internal/external audits, and training.

Duties

  • Investigate and track process deviations and quality issues across clinical operations
  • Monitor Key Quality Indicators to ensure non-conformances addressed and risk mitigated
  • Prepare GCP QA action summary and status reports for monthly and quarterly presentations
  • Ensure documentation and management of local corrective and preventive actions (CAPA) to support appropriate review and closure
  • Ensure country readiness for all GxPregulatory inspections. Provide support prior to, during and after audit inspections of the country organization, investigational sites or external service providers
  • Support and monitor implementation of the local Quality Plan (QP) deliverables related to GCP and pharmacovigilance areas

Skills and Experience

  • Degree qualified in Life Sciences or relative field
  • Minimum of 5 years' experience in Clinical Operations within the pharmaceutical industry in Australia
  • Preferably have at least 3 years' experience in GCP QA
  • High level of attention to detail with the ability to problem solve
  • Excellent communication skills and ability to liaise with stakeholders at all levels
  • Ability to write comprehensive and clear reports

Culture

Highly innovative company that rewards hard work, promotes inclusiveness and aims to improve the quality of patient's lives worldwide.

How to Apply

Click apply or contact Joanna Murphy, Specialist Manager on +61 2 8877 8718 for a confidential discussion.

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