Validation Manager
1 week ago
The Opportunity
CSL Seqirus, part of the CSL family, manufactures Products of National Significance (PNS) and Other Non-IVV (non-influenza) including anti-venoms, anti-toxins and Q-fever vaccinations. We are focused on saving lives all around the world through innovation and global collaboration.
We are looking for an experienced Validation Manager to join the great team at Parkville (Australia). This is a full-time, permanent or fixed term position (depending on your current employment status), where you will lead a small team to perform all aspects of quality validation to support changes to existing plant, equipment and processes for the Seqirus Australia business. You will also manage the delivery of the project validation requirements.
The Role
Reporting to the Senior Manager Validation and based on-site in Parkville (Australia), you will:
- Manage the preparation, review, implementation and maintenance of departmental documentation for all validation activities and regulatory submissions (i.e. Validation protocols and reports, Executive Summaries and Validation Master Files);- Promote the education and implementation of the requirements of the current TGA Code of Good Manufacturing Practice, US Code of Federal Regulations and other guidelines;- Manage the participation of the team in internal and external audits;- Provide leadership to the validation team to ensure performance is following the Business Plan and the Quality Management System and compliant with all codes, regulations and Seqirus policies.- Lead, coordinate and coach the team members including managing their development and performance appraisal;- Identify opportunities for improvement to optimise validation activities;- Measure and review the performance of projects against plans and provide regular updates on progress, resource issues and timelines to Quality Management.
Your skills and experience
To be considered for this role, you have:
- A degree in Science or Engineering;-
- 6+ years' experience with pharmaceutical industry guidance documents and standards including PICs;- 4+ years' experience leading a technical team in a regulated environment;- Experience in the pharmaceutical manufacturing industry;- Experience with statistical analysis software;- Experience in a role solving complex problems and collaborating across different departments;- Experience in a role requiring the completion of a range of different activities within timelines;- Experience presenting complex information both in writing and verbally.
How to Apply:
Our Benefits
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 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
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