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Form of workAbout the business
Tréidlia Biovet is a leading developer, manufacturer and marketer of specialty veterinary vaccines. Based at Seven Hills in Sydney, we produce a range of varied and interesting products, including bacterial, viral and recombinant. Join a growing team of talented and motivated professionals who are making an important contribution to animal health.
About the role
Due to continued growth we are seeking a proactive, positive team player to join our company as a Quality Assurance Associate. It involves a range of Quality assurance activities related to animal vaccine development and manufacture. Previous experience in the vaccine field would be highly advantageous, however candidates with experience in pharmaceuticals would also be considered. The successful candidate will have superior written, verbal & interpersonal communication skills, in particular the ability to produce clearly written, accurate, high-quality documents and reports.
Duties include:
- Assisting with the development and maintenance of the overall Quality Management System.
- Writing controlled documents such as SOPs, record templates and specs.
- Cross-checking of day-to-day production activities and batch manufacturing records.
- Perform line clearance and assist in batch release.
- Temperature monitoring of critical instruments and archiving of the data.
- Management of retention samples.
- Document archiving.
- Supplier qualification and service agreement management.
- Training management of Production, Quality & Warehouse department personnel.
- Performing internal audits of cross-functional departments and preparing the audit reports.
- Assisting with change control.
- Keeping trend analysis records up to date.
- Handling and troubleshooting autoclaves, dataloggers, warm rooms and other equipment.
- Taking part in training programs and/or training other staff.
- Maintaining accurate and comprehensive records of audit findings and decisions.
- Facilitating continuous improvement by ensuring long-term corrective actions are incorporated into processes to prevent reoccurrence.
- Ensuring OOS, Deviations, Product Complaints, CAPA and Recalls are investigated in collaboration with Production and other departments.
- Creating and issuing finished product labels
- Carrying out validations of manufacturing processes, QC tests, cleaning validation and equipment (IQ, OQ, PQ), and writing and reviewing validation protocols and reports.
- Training management of Production, Quality & Warehouse Department personnel.
- Performing internal audits of cross-functional departments and preparing the audit reports.
- Supplier qualification and service agreement management.
- Assisting in APVMA, OGTR, DAFF and supplier audits.
Benefits and perks
Interesting and varied work. Innovative new technologies. Competitive salary. Attendance at seminars and conferences. Happy team environment. WFH options after qualifying period.
Skills and experience
- Tertiary qualification in Science, ideally with a focus on microbiology.
- Demonstrated superior written, verbal & interpersonal communication skills. In particular the ability to produce clearly written, accurate, high quality documents and reports.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint). Good computing and data analysis skills.
- Knowledge of GMP, APVMA, PICs guidelines.
- Minimum 2 years of QA experience in the pharmaceutical/veterinary industry, ideally in a manufacturing environment.
- Exceptional attention to detail along with time management and multi-tasking skills.
- Ability to work independently and collaboratively, while following directives where necessary.
- Proficient in Microsoft Word and Excel.
- Experience with biologicals is desirable.
Please apply through seek with your cover letter and resume – please include details regarding your document and report writing experience.
