QA Batch Release Associate
CSL is a leading company in the pharmaceutical/biotech industry, committed to maintaining the highest standards of quality and compliance. We are looking for a dedicated QA Batch Release Associate to join our team and support our quality assurance processes.
This is a permanent, ongoing role based at our Broadmeadows site.
Responsibilities:
-
Ensure compliance with regulatory and site codes, including cGMP, FDA, and EU GMP guidelines.
-
Perform detailed record review of batch records and prepare batches for release.
-
Support product complaint and adverse event investigations.
-
Update batch release documentation and other site documents as required.
-
Participate in internal and regulatory inspections.
-
Collaborate with QA Value Stream groups and other departments.
-
Maintain QA Release Training SOP and ensure mandatory training is completed on time.
Qualifications:
-
Preferred tertiary qualification in Pharmaceutical, Biological Sciences, Biotechnology, or related field.
-
Some experience in the pharmaceutical industry is highly desirable.
-
Knowledge of cGMP, domestic and international regulations.
-
Tech-savvy (preferably SAP).
Please submit your resume and/or cover letter to be considered for the role.
Please note:This position is open only to Australian citizens and permanent residency visa holders.
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!
CSL is a leading company in the pharmaceutical/biotech industry, committed to maintaining the highest standards of quality and compliance. We are looking for a dedicated QA Batch Release Associate to join our team and support our quality assurance processes.
This is a permanent, ongoing role based at our Broadmeadows site.
Responsibilities:
-
Ensure compliance with regulatory and site codes, including cGMP, FDA, and EU GMP guidelines.
-
Perform detailed record review of batch records and prepare batches for release.
-
Support product complaint and adverse event investigations.
-
Update batch release documentation and other site documents as required.
-
Participate in internal and regulatory inspections.
-
Collaborate with QA Value Stream groups and other departments.
-
Maintain QA Release Training SOP and ensure mandatory training is completed on time.
Qualifications:
-
Preferred tertiary qualification in Pharmaceutical, Biological Sciences, Biotechnology, or related field.
-
Some experience in the pharmaceutical industry is highly desirable.
-
Knowledge of cGMP, domestic and international regulations.
-
Tech-savvy (preferably SAP).
Please submit your resume and/or cover letter to be considered for the role.
Please note:This position is open only to Australian citizens and permanent residency visa holders.
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!
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