Compliance Specialist
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 Compliance Associate to join our Quality Compliance team. Reporting to the Head of Compliance, you will work as a key member of the Quality Compliance team, ensuring that Aegros remains compliant with cGMP.
What you will be involved in
- Co-ordinating supplier approval activities to qualify the Supplier
- Performing Supplier Risk Assessments (Supplier Questionnaires, Agreements and ensuring that material supplied is fit for purpose for customer)
- Reviewing and assessing the documents related to Supplier Qualification
- Initialising, writing and reviewing Standard Operating Procedures relevant to QA Compliance
- Monitoring opportunities for continuous improvements to the quality systems through CAPA program
- Organising and performing internal GMP Audits, and external GMP audits
- Managing Regulatory Inspections and CAPA’s
- Co-ordinating product quality complaint investigations
- Performing full spectrum of functions of Compliance department
- Developing and implementing risk control strategies.
Requirements
What we would expect from you:
- Prior experience and understanding of quality systems particularly in a cGMP environment
- Experience working in pharmaceutical / Biopharmaceutical Quality Assurance or Compliance
- Experience with technical aspects of cGMP administration
- Previous experience in the assessment of deviations, change controls and CAPAs
- Exposure to sterile production and testing regulations both Australian and overseas is desirable
- Proficient with MS Excel amp; Word
- Excellent written and verbal communication skills
- A strong commitment to product quality and a continuous improvement mindset.
- Attention to detail
- Able to work autonomously while also being a part of a team.
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...!