AstraZeneca Pharmaceuticals LP Quality Compliance Specialist in Australia
At AstraZeneca we lead with the science first and foremost. As a patient centric global pharmaceutical company, we know that strong science leads to clinical innovation and the right medicine for the right patient. We are also excited about our enviable pipeline across many therapeutic areas. Importantly, we are keen to meet people who are passionate about the science and who want to make an impact on people’s lives.
AstraZeneca Australia is going through an exciting growth phase and you can be part of it! We have invested more than $200 Million in the last 8 years and our site continues to grow.
We have new opportunities for Quality Compliance Specialists at our North Ryde Manufacturing Division. This position is within the Quality Assurance function and will act to ensure our compliance activities are maintained to fulfil GMP and Regulatory requirements, by focussing on a range of Quality Systems. Every Compliance Specialist will look after (at least) one system at a time, on a rotational basis. The role will collaborate with other departments and external stakeholders to develop, address and enhance our processes and systems to ensure our product quality and compliance is maintained.
Responsibilities could include:
Maintain the Site Quality Systems in line with Global Quality Compliance Manuals and TGA cGMP requirements through the following activities
Administer the Deviation and Investigation Management system (Quality Notification System)
Manage the internal audit system
Ensure site readiness for regulatory and corporate (GQA) inspections, prepare responses track observations and maintain the closure evidence folders
Drive the site Vendor Management System
Maintain the Product Quality Review System
Manage site Customer Complaints, enter and track all complaints on the Global Complaints System, assist in investigation of complaints
Administer the Site Change Management process, ensure the relevant stakeholders assess changes
Administer Business As Usual activities to ensure site compliance to marketing authorizations
Provide support to Technical projects as required
You will be tertiary qualified in a science or quality related discipline and have a number of years working experience in a Pharmaceutical/Technical environment in Quality Assurance. Some basic knowledge & experience in Regulatory Affairs is highly desirable. You should demonstrate an ability to understand requirements prescribed within cGMP and Regulatory guidelines and how to apply these principles to maintaining compliance standards.
Most importantly, you are driven, proactive, confident and passionate about Quality.
Join AstraZeneca at an exciting time, and enjoy a range of benefits such as 10% super, bonus, leave loading, extra leave days, free parking & Gym membership. Develop your career in a world class environment.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.