Quality Assurance Compliance Specialist

1 week ago

Sydney, New South Wales, Australia AstraZeneca Full time

Quality Assurance Compliance Specialist

Do you have experience working in Quality Compliance with responsibility of providing both tactical and strategic leadership for Compliance and Quality Systems (QS) activities within operations or site? Would you like to apply your expertise and join an organisation that follows science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you

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

An exciting 12-month Full-time opportunity. Implement strategies to assure ongoing compliance and streamline processes to improve benefits and reduce complexity. Ensure efficient processes, procedures and quality systems are maintained within the boundaries of regulatory compliance for relevant GxPs. Work in a manner that protects the safety and well-being of self, others, and the environment.

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 center 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.

Benefits

An extra paid day off every month On-site car park and site staff canteen Gym membership

What you'll do

Reporting directly to the Compliance Manager, the Quality Compliance Specialist will be responsible for managing critical Compliance and QS programs and execute required activities to ensure the site meets current GMP requirements of all local/global regulations and internal AZ Quality and Compliance policies. Your responsibilities will include:

Driving continuous improvements efforts through monitoring of site systems and processes against current Compliance and Quality Systems requirements and influence key stakeholders on recommended Compliance improvements. Optimally managing Pharmaceutical Quality Systems. Overseeing the Site Quality Risk Management processes, including the maintenance of the Site Quality Risk Register. 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 Control Sound project management, prioritisation and multi-tasking skills. Knowledge of pharmaceutical laboratory functions Computer literate (Minitab, MS applications, Word, Excel etc.) Ability to understand requirements prescribed within cGMP 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 computerized management systems

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 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 . Please attach this as part of your supporting document. If you're curious to know more, please contact Dia Dutta.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Our website

Date Posted

22-May-2024

Closing Date

04-June-2024

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