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Quality Assurance Associate - Product Complaints

Job description

About the company

A highly successful and growing, global, bio-pharmaceutical company with an excellent reputation and a strong product pipeline.



About the opportunity

This is a 12 month contract role, with a possible extension. You will join an experienced and supportive Quality team. Your role will be responsible for product complaints. You will also support the broader QA function. Registering and triaging complaints, managing product returns, and supporting recall activities. You will ensure adequate investigations have been conducted to close-out complaints and ensure customer satisfaction.



Duties


  • Responsible for tracking, processing, and conducting follow up for Adverse Events and other safety information reportable to company and regulatory bodies.
  • Manage, triage, and prioritize information received into the QA inbox.
  • Ensure product complaints are registered in timely manner to meet regulatory and company requirements.
  • Implement the Customer Complaint system in accordance with internal SOPs.
  • Liaise with warehouse and logistics team to return and store product complaints.
  • Undertake adequate follow-up of complaints to ensure due diligence is performed.
  • Correspondence with customers to close out complaints and ensure customer satisfaction.
  • Conduct training on the Customer Complaint system for relevant stakeholders
  • Attend regular department meetings to support continuous feedback mechanisms.
  • Act as back up for product release oversight for distribution of products according to registered specifications to ensure compliance both in Australia and New Zealand, when required.

Skills and Experience


  • Bachelor's Degree in science, Pharmacy, or relevant discipline
  • Minimum 2 years' experience in the pharmaceutical or medical device industry.
  • Previous experience in Quality Assurance role working with product complaints
  • Understanding of requirements for medical device and pharmaceutical product complaints
  • Familiar with TGA and Medsafe regulations for therapeutic goods.
  • Effective communication
  • Strong project management skills
  • Ability to work autonomously and in a team environment.

Culture

Passionate about their work and their commitment to the patient. Promote wellbeing and support work-life balance. A positive, supportive, and collaborative working environment.


How to Apply


Click apply on the link to register your interest in the first instance, and if you have any questions please email Joanna Murphy, Specialist Manager - Regulatory Affairs & Quality Assurance on jmurphy@hpgconnect.com