Quality Assurance Manager

1 week 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.


About the role
We are seeking an experienced person to join our quality control and assurance team to perform a range of tasks including:

  • Perform full spectrum of QA functions and audits.
  • Setup and maintain QMS.
  • Ensure QMS and operational compliance with regulatory requirements.
  • Lead for key QMS systems such as audits, CAPA, SOP review, etc.
  • Support RA activities.
  • Setup and maintain QMS.
  • Lead in developing and implementing quality strategies.
  • Evaluates production capabilities and recommend improvements.
  • Deviation and compliant management, Products and Materials Release, Validation and Change Control Support, New production introduction and Documentation Controls to ensure an efficient operational Quality System that assures full compliance with company policies, regulatory requirements and cGMP
  • Responsible for ensuring that material supplied is fit for purpose for customer
  • Responsible for providing quality oversight for Operations activities
  • Ensure the effectiveness of investigations and to make decisions on the adequacy of investigations, root cause analysis and corrective and preventive actions
  • Ensure inspection readiness of the area with respect to all internal and external audits. When required provide responses and timely follow up on relevant corrective actions and commitments made as a result of the inspections, communicating with TGA, FDA and other regulatory agencies concerned if necessary.
  • Provide support/guidance for the implementation and maintenance of corporate and cGMP standards.
  • Any additional duties as assigned.

Requirements:

To be the successful applicant for this great opportunity you will have:

  • minimum of Bachelor of degree in Life Sciences (Chemistry, Microbiology, etc.) or equivalent,
- a minimum of 3 years' experience in managing and conducting Quality Assurance / Quality Management System functions in Pharmaceutical / Biopharmaceutical industry within Australia and Internationally,
- preferably with experience in cGMP working environment, start-ups, commissioning and qualification of process equipment in an operating plant;

  • Professional membership with Quality Assurance organization is beneficial.

Benefits

  • Supportive and friendly team
  • Rewarding culture
  • Weekly Fruits
  • Birthday Celebration

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