Manager, QA Cont Imp
1 week ago
The Opportunity:
Located in Parkville, Australia, the
Manager Quality Assurance Frontline (QA Validation)** is a full-time ongoing or fixed term position (depending on your current employment status).
You are pivotal role in raising the standards of the site, and you will work closely with Engineering, IT, Quality Control and Validation teams to deliver fully functional and compliant facilities, equipment, processes, systems and assays.
The Role:
Reporting to the Director of Frontline QA, you will:
- Ensure that our facilities, equipment, processes, systems and assays comply with all relevant regulations and satisfy the expectations of the Australian Therapeutic Goods Administration (TGA), United States Food and Drug Administration (FDA) and other international regulators;
- Liaise with key departments across the business, locally and internationally, to learn and provide guidance on quality standards and company expectations;
- Oversee and facilitating risk assessment processes so that project plans are robust and change appropriately management;
- Oversee of endtoend validation activities, with responsibilities for the approval of specifications, protocols (including execution), extractables and leachables assessments, and related reports;
- Provide leadership with a focus on measuring performance and continual improvement;
- Lead and developing a team of threetofour staff;
- Foster a culture of excellence in Environmental Health and Safety, including the assurance of worker health, wellbeing and resilience.
Your skills and experience:
To be considered for this role you have:
- Tertiary qualification in Science, Engineering or related fields;
- Minimum 8 years' experience in pharmaceutical manufacturing, including significant experience in validationrelated activities;
- Minimum 3 years' experience managing a team, with a demonstrated ability to lead teams of people to achieve an outcome;
- Experience and demonstrated understanding of Validation Standards (PIC/S, FDA and ISO13485), Quality Risk Management and GMP requirements;
- Experience within a global matrix organization;
- Excellent negotiating complex systems and collaborating to achieve practical and strategic solutions;
- Experience communicating complex information both verbally and in writing including experience in technical writing;
- Demonstrated attention to detail and ability to think analytically;
- Knowledge of Laboratory Information Systems, electronic Quality Management Systems (i.e. Trackwise), document management systems and SAP will be advantageous.
How to apply:
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number
R-203916 by
7th of August 2023
Our Benefits:
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
About CSL Seqirus:
CSL 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 us:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus:
**Watch our 'On the Front Line' video to learn more about CSL Seqirus
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