QA/RA Officer

Benefits

You will be instrumental in shaping and aligning Quality Management Systems and integrating new businesses.

This will be a pivotal role for the business over the next 3-5 years. Opportunity to make the role your own.

About the company

A leading, Australian, healthcare distribution company. Supply a large range of medical equipment and medical consumables on behalf of well-known medical brands. An established company who are rapidly expanding their market share.

About the opportunity

The RA/QA Officer will be responsible for the Quality Management Systems and ensuring compliance with company policies and regulatory body requirements. Main office based in South-West Sydney, with occasional travel to other sites in Vic, SA, and NZ. Role will report to Customer Experience Manager with dotted line to General Manager.

Duties

• Oversight, monitoring and reporting of company quality systems.
• Responsible for investigating non-conformances, implementing CAPA's and providing training to staff.
• Ensure Quality Management Systems are compliant with regulatory guidelines.
• Update and make improvements to current QMS.
• Generate QMS documents: SOP's, Work Instructions, and reports.
• Maintain Supplier management agreements.
• Organise calibration, qualification, and validation of equipment.
• Ensure company is audit-audit and provide support with external audits.
• Liaise with TGA, NICNAC/AICIS, NSW Health, Office of Drug Control to ensure products comply with distribution regulations.

Skills and Experience

• 3-5 years' experience in similar role working within healthcare industry.
• Knowledge of GMP, GWP, GDP for distribution of medical products in Australia
• Previous experience liaising with TGA, NICNAS, Office of Drug Control
• Solid knowledge of Quality Management Systems and ISO certifications
• Strong technical writing, reporting, and presentation skills are a must.
• Audit experience is highly desirable.
• Advanced skills in MS Excel, Word, Visio, and other MS applications
• Ability to influence and bring about desired changes.
• Must have clear communication and excellent interpersonal skills.
• Confident to liaise with stakeholders at all levels.

Culture

A fast-paced environment working with a team who are friendly and supportive. The company are focused on continuous improvement and the ideal person will have the ability to think outside the box and challenge the status quo.

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

( SK927795A )