Job Description

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QA Officer

Private Advertiser

Job Information

Job Listing Date
14 Oct 2020
Location
Gold Coast
Work Type
Full Time
Classification
Science & Technology, Quality Assurance & Control

Key Duties

  • Coordinate with production and supply chain department to ensure all work is in accordance with documented and validated procedures developed under the GMP rules.
  • Lead process, OOS, deviation investigations, change controls, risk assessments & validation activities & ensure closure of activities.
  • Implement change controls, assess changes and monitor CAPA's to ensure all issues are resolved.
  • Review manufacturing batch documentation & batch records to ensure compliance with quality standards.
  • Collaborate in Supply Chain conduct vendor assessment and materials control following current procedure
  • Response and resolute the internal and external audit findings

 

Requirement

  • Tertiary qualifications in Science or related discipline.
  • Specific 2 years plus pharmaceutical related industry experience is essential with a sound understanding of Regulatory Standards (TGA, FDA, EMA), GxP & Quality Assurance systems.
  • Specific operational experience with clean room practices, cell culture, protein purification and formulation manufacturing are highly desirable.
  • Good understanding of Quality Management systems.
  • Strong understanding of scientific concepts, technical aptitude & problem-solving skills.
  • Strong oral & written communication skills.
  • Ability to work independently & work well within a team environment.
  • Excellent attention to detail.
The application form will include these questions:
  • Which of the following statements best describes your right to work in Australia?
  • How many years' experience do you have in a quality assurance (QA) role?
  • Have you worked in a role which requires a sound understanding of Good Manufacturing Practices (GMP)?

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