Product Quality Advisor

2 weeks ago


Macquarie Park, Australia AstraZeneca Full time

Product Quality Advisor
We currently seeking a dynamic Product Quality Advisor to join our quality department and provide Quality Assurance support and technical advice to our Production and Support teams at North Ryde:

  • An exciting 12-month Full-time opportunity.
  • Make direct impact on the value stream by ensuring efficient processes and procedures 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 Quality Assurance Manager, the Product Quality Advisor will be responsible for ensuring processes and procedures are efficient and within the boundaries of regulatory compliance

Your responsibilities will include:

  • Providing quality assurance advice on GMP and impact on procedures /manufacturing compliance in the production area
  • Assisting in deviation management and performs initial deviation assessments and closure approvals
  • Proactively looking for opportunities to improve level of compliance and efficiency by suggesting improvements to the processes and procedures
  • Significant involvement in batch review and release activities
  • Contributing to the preparation of regulatory audits
  • Writing and approving relevant technical protocols/reports and standard operating procedures.
  • Review and assessment of imported finished goods

Essential for the role

  • Qualified to graduate or equivalent in a relevant scientific discipline
  • Experience in a Good Manufacturing Practice environment
  • Understanding of technical area of expertise
  • Understanding of the implementation of relevant Good x Practice (GXP)
  • Effective communication
  • Teamwork/collaboration
  • Proactive and able to work autonomously

Desirable for the role

  • SAP experience
  • PAS-X Experience
  • Sterile Manufacturing knowledge
  • Audit experience

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 ideas 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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