Quality Assurance Chemist
Full-time
Others
Macquarie Park, New South Wales
3 months ago
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 pro.....
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 lifesaving hyperimmune products.
An exciting opportunity has arisen for a Quality Assurance Chemist to work on a full time basis at our brand new facility in Sydney. Your role will be assisting the Quality manager in developing the company’s quality management system and assisting the team.
Duties of the role will include:
· Supporting the QA Manager in the set-up and maintenance of QMS.
· Ensuring QMS and operational compliance with regulatory requirements.
· Supporting for key QMS systems such as audits, CAPA, SOP review, etc
· Deviation, NCR and complaint management, Products and Materials Release, Validation and Change Control Support, New production introduction and Documentation Controls compliance with company policies, regulatory requirements and cGMP
· Responsible for ensuring that material supplied is fit for purpose for the customer
· Responsible for providing quality oversight for Operations activities
· Support the QA Manager in continuous improvement projects
· Assist in internal audits and the review of validation reports
· Issue and review batch documentation and release of batches of Intermediate, Bulk and Finished products.
You will bring:
· Life Sciences (Chemistry, Microbiology, etc.) academic degree with experience in Pharmaceutical / Biopharmaceutical industry and a minimum of 3 years in a QA role
· Experience in research and large-scale bioprocessing techniques in GMP environment
· An understanding and experience of quality systems and the need to develop and follow SOP
Benefits
Here’s what we can offer you…
· An environment which allows the individual to grow alongside the company
· A multicultural environment where every voice is heard
· Competitive remuneration package of $80,000 – $90,000 + Super +Bonus + Employee Share Options
· Benefits include additional leave for years of service, wellness leave, parental leave, paid additional leave
· Close to public transport
Interested? Apply today...!!!!
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