Quality Assurance Manager, Aegros Membrane Systems

4 weeks ago

Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

About Aegros

Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.

At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.

Over 30 years we have developed our HaemaFrac™ process which enables countries to turn human plasma they collected into life saving hyperimmune products.

It's no secret that Aegros is expanding rapidly An exciting opportunity has arisen for a Quality Manager to join the Aegros Membrane Systems business. Reporting to the Head of Quality Control Unit you will lead and manage the quality management systems ensuring compliance to regulatory requirements for Aegros Membrane Systems.

With prior working experience across ISO 9001, you will work on the full spectrum of QA functions covering deviation and compliance management, products and materials release, validation and change control support, new production introduction and documentation controls to ensure an efficient operational Quality System that assure full compliance with company policies, and regulatory requirements.

Requirements

  • Setting up and maintaining the QMS
  • Leading for key QMS systems such as audits, CAPA, SOP review, etc
  • Supporting regulatory affair activities as required
  • Developing and implementing quality strategies
  • Evaluating production capabilities and recommending improvements
  • Providing technical assessment and serving as a quality subject matter subject
  • Ensuring that materials supplied are fit for purpose for customer
  • Providing quality oversight for operations activities
  • Ensuring the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
  • Ensuring inspection readiness of the area with respect to all internal and external audits
  • Providing responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections,
  • Communicating with ISO, TGA, FDA and other regulatory agencies concerned if necessary
  • Providing support/guidance for the implementation and maintenance of corporate and regulatory standards.

Requirements

You will bring...

  • Tertiary education in Life Sciences, Chemistry, Microbiology or related fields
  • 4-8 years’ experience in managing and conducting Quality Assurance / Quality Management System functions within Pharmaceutical / Biopharmaceutical industry
  • Prior experience with ISO 9001 is mandatory to have
  • Experience in cGMP working environment, start-ups, commissioning and qualification of process equipment in an operating plant is desirable
  • Professional membership with Quality Assurance organization is beneficial
  • Excellent communication skills in English, verbally and written skills
  • Strong attention to detail with a collaborative approach to work.

Benefits

Here’s what we can offer you…

  • An environment which allows the individual to grow alongside the company
  • A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do
  • The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved
  • A multicultural environment where every voice is heard
  • Competitive remuneration package which includes an annual Bonus + Employee Share Options
  • Close to public transport


Interested? Apply today...

  • Quality Assurance Manager, Aegros Membrane Systems

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    **About Aegros** Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access. At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In...

  • Quality Control Manager

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our...

  • Production Manager

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Aegros Therapeutics Pty Ltd is a leading biopharmaceutical company dedicated to improving the lives of patients through innovative therapeutics. Our mission is to develop and produce high-quality plasma products that address unmet medical needs. We are currently seeking an experienced and motivated Production Manager to join our team. As a Production...

  • Head of Supply Chain Planning

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    About AegrosAegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a...

  • Project Manager, Procurement

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    About AegrosAegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a...

  • Validation Contractor

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Aegros Therapeutics Pty Ltd is looking for a Validation Contractor to join our team. As a Validation Contractor, you will play a crucial role in ensuring the quality and effectiveness of our therapeutic plasma products. Aegros is dedicated to transforming the lives of patients by providing a safe, secure, and sustainable supply of therapeutic plasma...

  • Validation Engineer Contractor

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Aegros Therapeutics Pty Ltd is looking for a Validation Contractor to join our team. As a Validation Engineer Contractor, you will play a crucial role in ensuring the quality and effectiveness of our therapeutic plasma products. Aegros is dedicated to transforming the lives of patients by providing a safe, secure, and sustainable supply of therapeutic plasma...

  • Facilities Coordinator

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access. At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our...

  • Senior Project Manager

    3 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    About AegrosAegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a...

  • QC Method Development

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access. At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our...

  • Project Administrator

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access. At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our...

  • Process Engineer

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    About AegrosAegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a...

  • Quality Assurance Associate

    6 days ago

    Macquarie Park, Australia AstraZeneca Full time

    **Quality Assurance Associate** We are looking for an experienced Quality Assurance Associate, to join our Quality Assurance team. - An exciting 12 months Fixed-term Full-time opportunity - Work in a manner which protects the safety and well-being of self, others, and the environment **About AstraZeneca** Join the team where everyone feels a personal...

  • Purchasing Officer

    4 weeks ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    Who we are...Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a...

  • Maintenance Fitter

    1 week ago

    Macquarie Park, Australia Aegros Therapeutics Pty Ltd Full time

    **Who we are** Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access. At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a...

  • Quality Assurance

    3 days ago

    Erskine Park, Australia Coles Group Full time

    From small everyday moments to larger-scale changes unique to a business like ours, you’ll really see the difference your work makes every day at Coles Group Manufacturing. Whether you’re in a distribution centre, a bakery, in-store or on the road, you’re an important part of an Aussie icon at the heart of the nation. **About the role**: A great...

  • Quality Assurance Manager

    4 weeks ago

    Osborne Park, Australia Ten Recruit Full time

    Manufacturing - Perth 30 November 2023 - Perm Role - Interviewing Immediately - Start before Christmas Ten Recruitment are currently seeking a Quality Assurance Manager for a client based in the Northern Suburbs of Perth. **About This Role** We are looking for a highly motivated and experienced individual to lead the Quality Assurance and Food Technology...

  • Quality Assurance Officer

    4 weeks ago

    Arndell Park, Australia Ventia Pty Limited Full time

    Be part of one of the largest essential service providers in Australia and New Zealand and be rewarded with professional development and career growth opportunities. **About the Role** As part of Ventia’s Sydney Roads Asset Performance Contract based in Arndell Park, the Quality Assurance Officer will work in the Business and Risk function. The role will...

  • Operations Manager

    4 weeks ago

    Macquarie Park, Australia UTOPIA Gaming Systems Full time

    Banktech Group Macquarie Park Information Technology & Communication Technology **UTOPIA Gaming Systems**, a part of The Banktech Group, is a leading gaming solutions provider servicing Australian clubs and hotels. It provides in-venue gaming systems and related services including cashless gaming, loyalty and Business intelligence systems and is at the...

  • Quality Assurance

    3 days ago

    Erskine Park, Australia coles Full time

    From small everyday moments to larger-scale changes unique to a business like ours, you’ll really see the difference your work makes every day at Coles Group Manufacturing. Whether you’re in a distribution centre, a bakery, in-store or on the road, you’re an important part of an Aussie icon at the heart of the nation. About the role A great...