
Quality Assurance Expert
5 days ago
About the Role:
We are seeking a highly skilled Quality Assurance Associate to join our team. In this role, you will be responsible for implementing and maintaining quality assurance processes and procedures in accordance with regulatory requirements and company standards.
Your Key Responsibilities:
- Assist in the implementation and maintenance of quality assurance processes and procedures in accordance with regulatory requirements and company standards.
- Support the Australia and New Zealand Quality Responsible Person (QRP) Lead with any recall matters.
- Contribute to the management of local vaccine release activities.
- Ensure periodic customer qualifications are performed in a timely manner.
- Collaborate with the Australia and New Zealand Lead QRP on quality and compliance related activities at our outsourced warehouses.
- Work closely with cross-functional teams to investigate and resolve quality issues, deviations, and non-conformances. Conduct root cause analysis and implement corrective and preventive actions.
- Support change control processes by assessing the impact of proposed changes on product quality and ensuring proper documentation and approval.
- Partner with internal teams to provide training and guidance on quality assurance processes, standards, and compliance requirements.
- Maintain accurate and up-to-date documentation related to quality assurance activities.
Your Requirements:
- Bachelor's degree in a related field, such as Pharmacology, Science, or Engineering.
- Strong attention to detail and excellent organizational skills.
- Knowledge of quality assurance principles and processes is advantageous but not essential.
- Familiarity with TGA and Medsafe regulatory requirements and industry standards is also advantageous but not essential.
- Good problem-solving and analytical skills, with the ability to conduct root cause analysis and implement corrective actions.
- Effective communication skills, both written and verbal.
- Ability to work well within a team and collaborate with cross-functional departments.
- Prior experience or internships in a quality assurance, operation, or regulatory role in the pharmaceutical industry is advantageous but not essential.
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