Senior Associate Pharmaceutical Quality Assurance Batch Release
Vor 6 Tagen
We are looking for a full-time Senior Associate, Quality Assurance (QA) Batch Release to join our diverse QA team in Parkville (Australia). This is a fixed term position until 31 August 2025. You will support the batch release of products, ensure ongoing compliance with domestic and international regulatory standards. You also will provide QA expertise to the site and work with manufacturing and quality control to achieve outcomes
The RoleReporting to the Manager QA Batch Release and based on site, you will:
- Review manufacturing documentation to ensure that raw materials, intermediates, and final products are suitable for further processing or release, and follow documented batch process sheets/procedures;
- Support maintenance of quality systems relating to batch release of finished products and manufacturing intermediates;
- Provide administrative support to the Senior Director QA & Quality Site Head / Quality Heads / Quality Managers at the Parkville site including data entry and review, for business systems;
- Oversee quality associates and support training and development;
- Participate in regulatory audits and projects;
- Identify and implement continuous improvements across Batch Release.
To be considered for this role, you have:
- A University degree in a relevant scientific discipline (Pharmacy, Chemistry, Microbiology, Biochemistry);
- 3-5 years' GMP experience in pharmaceutical/biotech or other regulated industry and applying current Good Manufacturing Practices (cGMP) principles;
- 2+ Experience with Regulatory Standards (TGA (PIC/S), FDA (CFR) and ISO-13485), Quality Risk Management, Quality Control and Quality Assurance systems;
- Experience working with quality and manufacturing teams to achieve outcomes
- Experience in a role requiring analysis and accuracy;
- Experience completing goals within established time frames;
- Knowledge of TrackWise, SAP, LIMS and documentation management systems.
Please send us your resume and covering letter (in one document), which addresses the skills and experience above and includes reference number R- 234621 by 25th June, 2024.
#LI-ONSITE
CSL 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 CSL Seqirus.
About CSL SeqirusCSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. In Australia, CSL Seqirus is also a leading provider of speciality pharmaceuticals and other essential vaccines. Learn more about CSL Seqirus .
We want CSL Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
quality assurance,pharmaceutical industry
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