QA OfficerPrivate Advertiser
- Job Listing Date
- 14 Oct 2020
- Gold Coast
- Work Type
- Full Time
- Science & Technology, Quality Assurance & Control
- 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
- 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)?