Our client is the most prominent and trusted contract sterilisation and decontamination processor in the Asia-PACIFIC region, and currently seeking a motivated and energetic Quality Assurance Officer to join their team in Craigieburn
- $42.14 per hour inclusive of casual loading per hour casual rate
- commencing asap
- Craigieburn location
- Tuesday to Saturday 6.30am- 3.00pm
- TGA-GMP environment experience essential
Key Duties And Responsibilities
- Ensure ongoing compliance with relevant legislation governing the company's business and operations.
- Document steps of the required processes in company controlled procedures.
- Maintain accurate and detailed records of quality assurance, quality control and process operational activities.
- Assist in recording, investigating, resolving and trending quality issues
- Assist in inventory monitoring of critical process consumables, facilitate purchases and execute verification checks and release-for-use of incoming goods.
- Assist in facilitating and partaking in (where duties dictate) site training regimes.
- Assist in hosting internal, external and regulatory audits including formulating responses to deficiencies.
- Receive customer product for processing,
perform quality verification checks and complete associated records.
- Initiate pre-programming irradiation recipes.
- Ensure appropriate labelling batches of customer product denoting the disposition.
- Ensure that all work is performed in accordance with the requirements of the Workplace Health & Safety Policy, procedures and legislation.
- Take reasonable care for own health & safety, as well as that of others.
- Compliance with all relevant safety practices including the reporting of hazards, near misses and incidents through safety system
Skills And Qualifications
- Minimum 2-3 years' experience in quality function within a manufacturing, pharmaceutical, healthcare workplace or other highly regulated industry.
- Sound understanding of Quality Management System requirement (preferably "ISO9001" and/or "ISO13485" and/or other highly regulated industry standard).
- Knowledge and experience in TGA Audits and/or other regulatory bodies.
- Sound judgment and decision-making abilities, often under pressure.
- Excellent communication skills.
- Solid level of attention to detail