Senior Quality Assurance Associate

About the company

A leading global biopharmaceutical company with a goal to provide healthcare based on biotechnology.

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About the opportunity

This is a commercial quality role and you will be responsible for the daily quality operations, specifically release for supply, managing non-conformances and complaints. Reporting to the Head of Quality, you will work closely with a small team of highly experienced QA professionals. We are looking for a collaborative, team player who can work independently and is passionate about quality compliance.

This will be a 12-month contract initially with a strong likelihood of becoming a permanent team member.

Duties

• Responsible for the release for supply in accordance with cGMP for all commercial and clinical trial products

• Inspect and accept incoming commercial shipments

• Manage any incidents relating to product quality including temperature excursions

• Write/review/approve local and global documentation

• Ensure all quality complaints are evaluated and investigated within company and regulatory timeframe expectations

• Liaise with supply chain on issues or customer complaints pertaining to supply and distribution

• Participate in audits of contract distribution and manufacturing sites in Australia

• Assist with the design and delivery of training to internal staff and third parties on quality compliance activities.

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Skills and Experience

• Must have experience in a Commercial Quality Assurance role within pharmaceutical industry

• Degree qualified in relevant science discipline

• Knowledge of GMP, GDP and related international and TGA/Medsafe guidelines

• Knowledge of ISO 9000 Quality Management Systems

• Experience in GMP auditing is desirable

• Ability to work effectively in a team environment on multiple projects

• Proven ability to understand technical, scientific and medical information

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How to Apply

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

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( SK927795A )

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