Quality Assurance Associate
We are seeking an experienced Quality Assurance Associate for a permanent fulltime role to increase our Quality function and support the growing demands of the business as we are expanding worldwide.
This role is responsible for supporting the business in the maintenance and management of the QMS (Quality Management System) and supporting the factory to meet global cGMP guidelines.
- Providing advice, guidance, and recommendations to support the manufacturing teams and processes
- Support, investigation, and assessment of Non-Conformances/Deviations and complaints
- Support and implementation of Corrective and Preventive Actions (CAPA)
- Review and release of raw materials
- Reviewing completed batch documentation to support the release of intermediates and finished goods
- Review, update, creation, and approval of documents such as SOPs, batch manufacturing instructions, specifications, and work instructions.
- Administration, QA input, and support in the use of Change Control throughout the business
- Preparation and approval of COAs
- Review and approval of R&D project documentation
- Performing internal audits and preparation for audits by external bodies (TGA, APVMA, FDA) and the close out of identified observations
- Support new product introductions
- Working with the Logistics team to maintain quality requirements for external suppliers
- Ensuring compliance with national and international standards and legislation.
We are looking for a team player with previous experience in a similar role within the pharmaceutical/animal health industry. Ideally, you will possess the following skills and experience:
- Minimum 2 years quality assurance or manufacturing/operations experience in the pharmaceutical or veterinary pharmaceutical industry.
- Experience in a GMP manufacturing environment
- Knowledge of Quality Assurance in pharmaceutical or veterinary pharmaceutical products
- Strong organisational and problem-solving skills.
- Demonstrated ability to build strong collaborative relationships with stakeholders
If your experience, skills and educational qualifications fit this profile, please submit your application via SEEK before 24th March 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