Quality Assurance Specialist

2 weeks ago

Melbourne, Australia Heng & Hurst Full time

Ongoing Part Time QA Role 5 days a week 12-5pm
- Strong GDP experience required
- Hybrid working arrangements office days and WFH

This niche biopharmaceutical company are leaders in driving innovation in the areas they specialise. Being a specialist focused company, their culture is driven by dynamic, passionate, and collaborative professionals. Their products are highly regarded in treating patients across multiple therapeutic areas. They are looking for a Quality Assurance Specialist to manage the Australian and New Zealand market.

Reporting to the Regional Quality Lead, your responsibilities will include:

- ensuring global quality practices are integrated in Australia to ensure compliance and safety obligations are met with local regulations
- maintaining the GxP status of the business in accordance with national and international legal requirements
- managing the local Quality Management System
- assisting in the identification and mitigation of issues and risks, highlight improvement opportunities and facilitating the development of solutions
- engaging with multiple stakeholders both locally and globally
- Tertiary qualification
- Demonstrated experience in a Quality Assurance role in the Pharmaceutical industry
- Operational GDP experience would be highly regarded
- Experience interacting with regulatory bodies and third party organisations with respect to QA systems would be an advantage
- Good quality auditing mindset and risk management/assessment skills
- Ability to work with multiple internal and external stakeholders both locally and globally

Most of all you will enjoy working in a challenging and integral role where you will engage with a variety of stakeholders who have the patient as the core focus of everything they do. On offer is the opportunity to work closely with your cross-functional peers, excellent pipeline of products and in a role where you will be the local expert in Quality Assurance

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