R&D Quality Associate
- Full Time Position
- Located in Rutherford, Hunter Valley, NSW
Jurox is a 100% Australian owned Animal Health Company based at Rutherford in the Hunter Valley, NSW. Our products are sold to veterinarians, consumers and rural merchandise outlets in Australia, New Zealand, Asia, Europe and North America.
We are seeking a suitably experienced R&D Quality Associate is to assist in the management of our quality system, ensure documentation is meeting the required standards, and to perform audits within the R&D department to all levels of GLP and GCP compliance.
Tasks will include, but are not limited to:
- Performing independent quality reviews of R&D documents including study plans, reports and SOPs.
- Maintaining knowledge and understanding of current guidelines and regulations; specifically GLP and GCP.
- Performing internal audits.
- Perform auditing of studies to ensure GLP, including to 21 CFR Part 58, compliance is maintained.
- Assist in preparation, approval, review and maintenance of the R&D quality system manual, standard operating procedures, and other related documents as required (including specifically all processes and SOPs related to the QA role).
- Serve as a Monitor on GCP studies when requested by Management.
- Review and assist with improvements to the R&D quality system through advising TFM and R&D staff on compliance to relevant quality standards, including identification of deviations from GLP.
- Assist TFM in managing the Corrective/Preventative Action (CPA) process.
- Support NATA requirements and audits as required.
- Bachelor Degree in Quality Management, Science or Pharmaceutical Science or equivalent
- Minimum two years’ experience in quality assurance and control.
- Knowledge of Quality Management Systems.
- Knowledge of document and record management practices
- Excellent communication, negotiating and timekeeping skills.
- Ability to handle large amounts of technical information.
- Knowledge of regulatory and quality (GLP, GCP) requirements.
- Strong capability with Microsoft suite of applications – Word, Excel, PowerPoint.
- Experience in pharmaceutical and animal health industries highly regarded.
If your experience, skills and educational qualifications fit this profile, please submit your application via SEEK before midnight on the 26th April 2019 to ensure that you are considered for the role.
RECRUITMENT AGENCIES NEED NOT APPLY
Only those with the existing right to work in Australia will be considered