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QA Specialist

Our Client a manufacturer in the sterile Pharmaceutical area is looking for a QA Specialist to join their team!

Our client, a manufacturer and supplier of Therapeutic Plasma Products, is an organisation that strives to place the patient 1st by providing therapeutic plasma products they would not otherwise be able to access. They pride themselves on their drive and passion to utilise new and improved technology to deliver safer and more affordable products to their customers.

Due to this development they have a fantastic opportunity for a QA Specialist to join their organisation in a hands on role that allows you to use your skills and knowledge in an innovative and forward thinking business.

The organisation has strong growth plans both domestic and global so we feel that this is the perfect time to come on board and accelerate your career

As the QA Specialist you will:

  • Set-up and maintain Quality Management System QMS).
  • Ensure QMS and operational compliance with regulatory requirements.
  • Act as the lead for key QMS systems activities such as audits, CAPAs, SOP review, etc.
  • Act as the lead in developing and implementing quality strategies as provided by Corporate RAQA.
  • Evaluate production Quality and Compliance capabilities and recommend improvements.
  • Implement and manage the Documentation Controls to ensure an efficient operational QMS that assures full compliance with company policies, regulatory requirements and cGMPs
  • Responsible for providing quality oversight for Operations activities
  • Ensure the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
  • Ensure inspection readiness of the area with respect to all internal and external audits. When required provide responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections, communicating with TGA and International agencies, (e.g. FDA and other regulatory agencies) under the guidance of Corporate RAQA.
  • Manage Internal Quality Audit program form planning, implementation, gather feedback and re-audit as required
  • Perform full spectrum of QA function and support RA activities.
  • Provide technical assessment and serve as QMS subject matter expert.

In order to be considered you will have:

  • Tertiary Qualifications in Life Sciences (Chemistry, Microbiology, etc.) academic degree
  • Professional experience (3 to 6 years) in managing and conducting Quality Assurance / Quality Management System functions in Pharmaceutical / Biopharmaceutical industry within Australia and Internationally
  • Strong project management skills
  • Strong interpersonal and communication skills
  • Meticulous in planning and execution
  • Ability to grasp new concepts quickly and to assimilate data from a range of scientific ideas.
  • Ability to work under pressure and to strict guideline
  • Perform all duties in a timely manner compliant with the Australian Code of Good Manufacturing Practice.