Quality Assurance Compliance Specialist

1 week ago

Macquarie Park, Australia AstraZeneca Full time

Quality Assurance Compliance Specialist
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 wellbeing 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
  • Onsite 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/followup 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 multitasking skills.
  • Knowledge of pharmaceutical laboratory functions
  • Teamplayer 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.


AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA).

As an organisation we stand with confidence on our gender equality initiatives including pay equity, leadership development programs, and zero tolerance for gender-based harassment.

This achievement exemplifies our commitment to building high performing, inclusive and diverse teams that collaborate across our enterprise, aligned to our values and strategic priority of being a Great Place to Work.


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.
  • If you're curious to know more, please contact Dia Dutta. Applications close Tuesday 12 September 2023.
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