Quality Assurance Associate

3 weeks ago

Warriewood, Australia Clinigen Full time

Link Healthcare, a Clinigen company, is a growing specialty pharmaceutical services company, with one clear aim: to accelerate access to medicines for people around the world.

To achieve our aim, we work with a global pharma, biotech and a network of suppliers, to source hard-to-get medicines, navigate complex regulatory environments and provide access to patients who need them.

Our Quality Assurance Associate role presents a great opportunity for you to step up your career in Quality. This role will see you support the delivery of operational excellence and implementation of all Quality Assurance functions for our ANZ warehouse facilities, ensuring these functions are performed in compliance with company policies, ISO, GDP and GMP requirements and as required by local issuing authorities.

**Responsibilities**

On a day to day basis, this role will see you:

- Support change control processes
- Support investigations, root cause analysis and implementation of CAPAs
- Support, track and maintain reported deviations and customer complaints
- Support our team with document control and administrative activities
- Support training activities across the business and ensure the maintenance of training records
- Participate in inspection activities
- Support with vendor management
- Contribute to our small team to continue to build our local operations and maintain robust QMS

**Requirements**:
To be successful in this role, you'll need:

- Demonstrated experience in operational roles within a pharmacy, pharmaceutical company or warehouse environment
- Excellent verbal and written communication skills
- Ability to work autonomously, as well as collaboratively across teams
- Exposure to GDP and GMP quality management systems highly regarded
- Results, action oriented, tenacity, and resilient
- Motivated and adaptable, with a proactive approach to problem solving

**Benefits**

In return, we can offer:

- Competitive remuneration
- Annual performance bonus
- Flexible working arrangements
- Ongoing support for professional development
- Paid parental leave
- Onsite parking in our offices and warehouse

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