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QA Associate
2 weeks ago
Job Description
The role holder will be a Quality member of the Secondary Frontline QA team.
- The role holder will be responsible for providing cGMP and Quality support and guidance to the Secondary projects/operations (Filling, Inspection, and Packaging) and its support functions.
- The role will be required to perform QA Frontline duties during campaign operation of the Fill/Finish production lines (Filling, Inspection, Packaging), including technical and qualification batches as required.
- The role holder will also be required to provide QA support to the wider business, as and when required by the Quality Assurance Manager.
- The role holder will be responsible for QA review and approval of procedures, batch production records (master and executed), and any other relevant cGMP documentation.
The role holder will work as a member of cross-functional teams as defined by the Quality Assurance Manager. The role holder must be confident in making Frontline Quality decisions.
QA frontline support; documentation review and approval:
- To ensure and facilitate cGMP behaviours, including aseptic behaviours where required, in order to ensure compliance with cGMP requirements, and to safeguard product quality and sterility assurance.
- To review and approve procedures, master batch product documents, and any other technical or cGMP documentation in accordance with procedures, cGMP and license requirements.
- To provide frontline QA support for Secondary operations (as well as QA support to the wider business when required) including the QA review/approval of manufacturing batch records and other related cGMP documentation.
- To ensure that other team objectives are achieved: support the execution of the work plan; and, suggest/implement improvements.
Participate in projects:
- To be a member of the Liverpool Secondary projects team for Quality.
- To author, review and approve associated cGMP/EHS documentation.
- To drive quality decisions and provide advice and technical support.
- To demonstrate creative problem solving within cGMP constraints and align with best practice.
- To support other projects and improvement exercises as required.
Deviation/CAPA and Quality System support:
- To provide support for deviation investigations, ensuring effective root cause analysis investigations are performed and product quality implications accurately assessed. Identify repeat deviations and ensure appropriate corrective actions are taken.
- To ensure that deviations, CAPAs, protocols/reports and other applicable documents are reviewed and approved within the designated timelines.
To promote a Safety, Quality and cGMP culture in the team and across the site:
- To provide Quality oversight for manufacturing and support functions ensuring that appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team and site areas of responsibility, in accordance with current regulations and procedures.
- To deliver continuous improvement of quality related metrics across all manufacturing and support departments.
- To work in alignment with the Seqirus values at all times and in all aspects of work.
- To be permanently inspection ready and prepared to participate as applicable.
To perform training required for own role and keep own training records up to date:
- To participate in coaching and feedback of trainee colleagues as applicable.
- To manage organisational change and process improvements as applicable.
Minimum Education Requirements
Graduate (degree) in a scientific discipline.
Minimum Experience Requirements
Minimum of 2 years’ Shop Floor QA experience on a pharmaceutical site with an MIA. Including: Experience in Aseptic Filling; and, experience in Automatic Visual Inspection (AVI) & Packaging.
Our Benefits
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits
you can participate in when you join Seqirus.
About Seqirus
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus
We want Seqirus 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 Seqirus.
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