QA Assurance Specialist

1 day ago

Melbourne, Victoria, Australia beBeeQuality Full time $90,000 - $120,000

**Quality Assurance Specialist Role**

We are seeking a Quality Assurance professional to support our quality team, focusing on process integrity, record approval, quality risk assessments, non-conformance management, investigation oversight, CAPAs, change control management, and continuous improvement of quality performance metrics.

The ideal candidate will report to the QA Manager and be responsible for:

* Providing real-time and post-event quality oversight
* Performing QA approval of operational and processing records to ensure compliance with regulatory requirements
* Reviewing documentation required for batch disposition
* Assessing and escalating identified issues to meet batch release timelines
* Managing deviation processes, including risk assessments, root cause analysis, and CAPAs, as well as supporting change control processes

The successful candidate should possess a Bachelor's degree in science, Engineering, Biotechnology, Biological Sciences, Pharmaceutical Science, or equivalent, along with 3+ years of experience in a similar role within pharmaceutical manufacturing or quality assurance. Strong knowledge of GMP, regulatory requirements, and quality compliance is essential, along with experience in deviation management, investigations, and CAPA. Excellent problem-solving, organizational, and interpersonal skills are also required.

This role offers a unique opportunity to contribute to the success of our organization by ensuring the highest quality standards are met.

The successful candidate will have the opportunity to work in a dynamic environment with a team of experienced professionals who share a passion for delivering high-quality products.

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