Senior Specialist – Quality Compliance (24m contract)

About AstraZeneca

Join a team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering the highest quality. It’s inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people’s lives better – from patients and their families to all of us in society.

The North Ryde manufacturing facility remains an important centre for both AstraZeneca and manufacturing in Australia.  We are proud of our long heritage in Australia, where for more than 65 years, AstraZeneca has been providing medicines to treat many cancers and chronic diseases, saving lives and extending life for millions of Australians.

What you’ll do

We are currently seeking a dynamic Senior Quality Compliance Specialist to join our quality department and provide quality assurance and compliance support as well as technical advice to our Production and Support teams at North Ryde.

Reporting directly to the Associate Director Quality Assurance, this role will be responsible for managing critical Compliance and Quality Systems to execute required activities and ensure the site meets current GMP requirements of all local/global regulations as well as internal AZ Quality and Compliance policies.

Your responsibilities will include:

• Optimally managing Pharmaceutical Quality Systems (such as Deviation, CAPA, Change Control, Self Inspections, Product Quality Reviews, Supplier mgmt. & Risk mgmt.) ensuring current Compliance and Quality Systems requirements are met and delivering quality system performance against KPI.

• Driving continuous improvements efforts through monitoring of site systems and processes and influence key stakeholders on recommended Compliance improvements.

• Supporting the preparation, planning & logistics, inspection management, and response/follow-up for Customer and Regulatory Agency Inspections.

• Taking end to end ownership to resolve quality compliance issues, coordinating key stakeholders to reach a resolution.

Essential for the role

• Tertiary qualifications in a science or quality related discipline

• Minimum 3 years working experience in a Pharmaceutical/Technical environment in Quality

• Proven experience with quality systems

• Ability to understand requirements prescribed within GMP guidelines and how to apply these principles to maintain compliance standards

• Team-player with an ability to work independently

• Good analytical, written and oral communications skills

Desirable for the role

• Experience in multiple areas of quality assurance within a pharmaceutical manufacturing environment

• Knowledge of sterile manufacturing

• Knowledge of computerised management systems (Veeva)

Why AstraZeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.  

Part of an inclusive and giving community, we support and help each other on our journeys –backed by the same personal commitment to each other as we give to patients. Curious problem solvers, we are intellectually stimulated by constant learning. There’s potential for multiple, global careers and great rewards, for those who embrace the diverse opportunities.

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Bronze Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page to learn more about our commitment to fostering a flexible, diverse, and inclusive environment.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have a seat available, and we hope it’s yours.

• Please note that all internal applications must be accompanied by a Talent Card. Please see link to assist you with creating your Talent Card https://nucleusvideo.astrazeneca.com/media/t/1_ul5bvxgy/67879971. Please attach this as part of your supporting document.

• If you’re curious to know more, please contact Sylvia Chand.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

• Our website https://www.astrazeneca.com.au/

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.