Quality Control Team LeaderAustraliaR-0997823085 Seqirus Australia
With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
A key business activity is the quality control (QC) testing of our products which supports the release of products to market. Located in Parkville (Australia), this is a full time permanent role for an experienced QC Microbiology Team Leader to lead and manage a a team of specialists and analysts, to undertake bacteriology testing to ensure compliance with GMP and QMS.
Reporting to QC Manager, key responsibilities in this role will include:
- Scheduling testing and allocating resources to meet customer requirements and departmental KPIs and support product release;
- Ensuring the QC facility is GMP compliant and all processes and procedures are conducted in accordance with approved procedures;
- Overseeing the training and compliance requirements of all operators involved in assay execution;
- Oversee the reviewing, updating and issuing of relevant QC documentation and ensure the team is audit ready at all times;
- Participate in investigations relating to deviations, CAPAs and change controls as and when required;
- Actively seeking, recommending and implementing improvements to proactively minimise invalid assays, minimise costs and maximise efficiency;
- Coaching, managing and inspiring your team, to achieve operational outcomes including reviewing and assess work performance.
The successful candidate must possess:
- Tertiary qualifications in a related scientific discipline or substantial on the job experience;
- Strong technical understanding of pharmaceutical manufacturing and/or testing processes;
- Demonstrated understanding and experience in the practical application of relevant GxP and ICH;
- Practical experience with quality systems and laboratory information management systems such as LIMS or GLIMS;
- Experience in managing a production or qualiy area, including working with targets and objectives;
- High level of attention to detail and impressive problem solving skills;
- Demonstrated customer focus;
- Excellent written and verbal communication skills;
If you are looking to develop your skills and shape the health of Australians, please apply with your resume and cover letter, which must address the selection criteria above, and include the reference number R-099782.
Applications will close on 6th September, 2019
CSL advises that screening including; criminal history, medical assessment, confirmation of experience, stated qualifications and other relevant checks form a part of the candidate suitability evaluation process. Where applicable, this applies to current CSL employees. CSL employees must notify their current manager when selected for interview for any advertised internal vacancies.