Senior Quality Assurance Professional

1 week ago

Sydney, New South Wales, Australia beBeeQuality Full time $150,000 - $200,000

About Aegros

A company prioritizes patient care and accessibility to life-saving therapeutic plasma drugs.

Our mission is to put patients first through innovation, making access to these drugs a human right rather than a privilege.

With over 30 years of experience developing the HaemaFrac process, we enable countries to turn collected human plasma into life-saving hyperimmune products.

We seek an experienced Quality Assurance Manager to lead and manage our quality management systems, ensuring compliance with regulatory requirements.

This includes setting up and maintaining QMS, leading key QMS systems, supporting regulatory affairs activities, developing and implementing quality strategies, and evaluating production capabilities.

The ideal candidate will have tertiary education in Life Sciences, Chemistry, Microbiology or related fields, and 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, and experience in cGMP working environment, start-ups, commissioning and qualification of process equipment in an operating plant is desirable.

The successful candidate will also have professional membership with Quality Assurance organization, excellent communication skills in English, verbal and written skills, and strong attention to detail with a collaborative approach to work.

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