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Clinigen

Quality Assurance Associate - ANZ

Posted 7 Days Ago
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Wood Glen, New South Wales
Entry level
Wood Glen, New South Wales
Entry level
As a Quality Assurance Associate, you will support operational excellence and implement Quality Assurance functions in compliance with ISO, GDP, and GMP standards. Responsibilities include change control processes, investigations, training maintenance, and maintaining the Quality Management System (QMS).
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Description

Link Healthcare, a Clinigen company, is a growing specialty pharmaceutical services company, with one clear aim: to accelerate access to medicines for people around the world. 


To achieve our aim, we work with a global pharma, biotech and a network of suppliers, to source hard-to-get medicines, navigate complex regulatory environments and provide access to patients who need them.

Our Quality Assurance Associate role presents a great opportunity for you to step up your career in Quality. This role will see you support the delivery of operational excellence and implementation of all Quality Assurance functions for our ANZ warehouse facilities, ensuring these functions are performed in compliance with company policies, ISO, GDP and GMP requirements and as required by local issuing authorities.

Responsibilities

On a day to day basis, this role will see you:

  • Support change control processes
  • Develop your understanding of quality risk management principles and apply these in your daily work
  • Support investigations, root cause analysis and implementation of CAPAs
  • Support, track and maintain reported deviations and customer complaints
  • Support our team with document control and administrative activities
  • Support training activities across the business and ensure the maintenance of training records
  • Participate in inspection activities
  • Support with vendor management
  • Contribute to our small team to continue to build our local operations and maintain robust QMS
Requirements

To be successful in this role, you'll need:

  • Demonstrated experience in operational roles within a pharmacy, pharmaceutical company or warehouse environment
  • Excellent verbal and written communication skills
  • Ability to work autonomously, as well as collaboratively across teams
  • Exposure to GDP and GMP quality management systems highly regarded
  • Results, action oriented, tenacity, and resilient
  • Motivated and adaptable, with a proactive approach to problem solving
Benefits

In return, we can offer:

  • Competitive remuneration
  • Annual performance bonus
  • Flexible working arrangements
  • Ongoing support for professional development
  • Paid parental leave
  • Onsite parking in our offices and warehouse

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