Senior Manufacturing QA
Aegros Therapeutics Pty Ltd, Australia
Job Description
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 Senior Manufacturing QA Associate to join our Quality Assurance team. Reporting to Quality Assurance Manager, you will provide support in developing the company’s quality management system and assist peers with the daily running of the Quality Assurance Department.
What you will be involved in
• Audit of production and QC documentation.
• Perform line clearance, pre and post production run.
• Support the QA Manager in the set-up and maintenance of QMS.
• Ensure QMS and operational compliance with regulatory requirements.
• Support for key QMS systems such as audits, CAPA, SOP review, etc.
• Support RA activities.
• Support in developing and implementing quality strategies.
• Deviation, NCR and complaint 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.
• Support the QA Manager in continuous improvement projects and quality related improvement initiatives.
• 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.
Requirements
What we would expect from you:
• Life Sciences (Chemistry, Microbiology, etc.) academic degree with experience in Pharmaceutical / Biopharmaceutical industry within Australia and Internationally.
• Experience in research and large-scale bioprocessing techniques.
• An understanding and experience of quality systems and the need to develop and follow SOPs, particularly in a cGMP environment.
• Strong interpersonal and communication skills.
• Ability to grasp new concepts quickly and to assimilate data from a range of scientific ideas.
• Ability to work under pressure and to strict guidelines.
• Ability to manage time and to delegate as appropriate.
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...!