About 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 initially on a 12 month contract. It involves a range of Quality Assurance GMP 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, sound GMP knowledge, 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 Specifications.Ensuring OOS, Deviations, Product Complaints, CAPA and Recalls are investigated in collaboration with Production and other departments. Cross-checking of day-to-day production activities and batch records.Perform line clearances and assist in batch release duties.Temperature Monitoring of critical instruments and archiving of the data.Management of Retention samples.Document Archiving.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.Performing internal audits and preparing reports.Creating and issuing finished product labels Assisting with validations of manufacturing processes, QC tests, hygiene procedures and equipment (IQ, OQ, PQ), and writing and reviewing validation protocols.Assisting in APVMA, OGTR, DAFF and internal / supplier audits. Benefits and perks Interesting and varied work. Innovative new technologies. Competitive salary. Attendance at seminars and conferences. Happy team environment.
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 GMP 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.