Quality Assurance Associate (Entry Level)

Benefits

• Busy fulltime permanent role!
• Leading pharmaceutical company
• Excellent company culture

About the company

This pharmaceutical company is one of the fastest growing pharmaceutical companies in Australia, and a leading provider of high-quality medicines, with a continuously expanding and comprehensive product portfolio and healthcare expertise.

About the opportunity

In this busy Quality Assurance Associate role, you will be responsible for product complaints and enquiries, maintenance of the change control system, pharmacovigilance duties, and regulatory affairs/product development assistance activities.

Duties

• Product Complaints and Enquiries:

o Case logging for all incoming product complaints, adverse drug events and medical information queries.

o Assisting with investigation as necessary.

• Change Control System:
• Maintain change control system.
• Assist in review and management of deviations, non-conformances and other items.
• Pharmacovigilance:
• Ensure all adverse drug events are reported to the pharmacovigilance team, and other parties as required, in the required timeframes.
• Performing monthly reconciliations with relevant suppliers in accordance with safety and pharmacovigilance agreements.
• Maintain and review current product quality documentation for all products.
• Assist with maintenance of patient support programs as required.
• Regular reporting to pharmacovigilance team.
• Regulatory Affairs/Product Development Assistance Activities:
• Assist with preparation and review of product artwork and information, and consumer medicine information as required.
• Assist with procurement of samples to support product development projects.
• Respond to requests from medical information providers.
• Internal communication of pricing updates.
• Other Ad Hoc Activities

Skills and Experience

• Relevant experience/educational background highly valued
• Knowledge of the pharmaceutical industry highly valued
• Good attention to detail
• Flexible and adaptable
• Team orientated

Culture

Friendly and collaborative team culture; with the commitment to supporting the health and better health outcomes for patients through the highest standards of integrity.