Senior Associate Quality Assurance Compliance
job description
The Opportunity
Join the CSL Behring Quality Assurance (QA) Compliance team for an 18-month fixed term contract or secondment. As the Senior Associate Quality Assurance Compliance working on-site at Broadmeadows, you will co-ordinate self-inspection (internal audits) and regulatory inspection readiness programs. You will also prepare reports on self-inspection performance and ensure the findings are addressed by relevant responsible owners.
The Role
Working on-site and reporting to the Manager Quality Assurance Compliance, you will participate in the following compliance activities:
Perform self-inspections observing the site self-inspection schedule and maintain the self-inspection program
Quality programmes and taskforces as they arise from different sources and issues
Preparation for external inspections and the site's regulatory inspections and then manage the Corrective Action Plans for compliant responses to findings and their closeout
Initiate and manage impact assessments of new regulatory requirements
Manage all Corrective and Preventive Actions (CAPA) resulting from the Regulatory Alert impact assessments and provide reports as part of the Quality Management Review Process
Your skills and experience
To be considered for this role you have:
A degree in science or engineering or pharmaceutical science
3+ years' experience in the pharmaceutical manufacturing industry in a cGxP environment
Experience with cGxP regulatory requirements including industry guidance documents such as those required by TGA or FDA
Experience preparing for and co-ordinating self-inspections and external inspections
Experience working with information databases and reporting
Experience preparing written technical documents and presenting complex information
Experience in a role requiring conceptual and analytical thinking to reconcile ambiguities.
How to Apply:
Please apply with your resume and covering letter, which must address the selection criteria above, and include the reference number R-229775 by May 12th, 2024.
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity &
Inclusion at CSL.
Do work that matters at CSL Behring!