Reporting to the QC Analytical and Raw Materials Manager, you will be providing technical leadership and co-ordinating the activities of work allocated to the team; specifically, the sampling and testing of quality control samples of Primary and Secondary Packaging materials, Raw Materials and Excipients. 

You will manage organisational change and process improvements through development of a team.  Maintaining a presence within the laboratory area to monitor laboratory activities.

You will coordinate and ensure that team goals are achieved and operational decisions made and performed promptly.

You will manage the specified team providing coordination of all activities to ensure compliance with regulatory requirements, GLP and company SOPs.  To ensure that all scheduling requirements are met, together with other departments where required.

Responsibilities

To provide direction to the team and ensure that mandatory training is in place.  To encourage performance of staff through training, feedback and development planning together with the manager.  To track attendance and timekeeping and assist disciplinary / counselling sessions.  Actively promote positive change.

To ensure appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team, in accordance with current regulations and procedures. To be permanently inspection ready. To ensure that the maintenance and qualification of the specified laboratory and equipment within is up to date and at the required GMP standards.  To ensure the use only of approved and validated test processes.

To review and approve data generated from testing and to bring to the attention of the team manager and other site personnel test results and any trends, out of specification results.  To perform testing activities.  Also, where appropriate, perform the required transactions to release materials in the electronic LIMS (Laboratory Information Management System) & SAP. Where appropriate & possible troubleshoot in the resolution of testing problems involving your team and customers/suppliers.  Demonstrate problem solving within cGMP constraints and align with best practice.  Manage department cGMP systems, such as deviation management (Leading complex technical investigations), closure of corrective & preventative actions, change controls and SOPs.

To participate in improvement project teams where required, driving quality decisions and provide advice and technical support where required.  Coordinate completion of any resulting activities.

Education Requirements

Graduate level in relevant STEM discipline or suitable alternative or equivalent experience within industry

Experience Requirements

Minimum 3-year experience, within the pharmaceutical or manufacturing industry, having worked to GxP standard.

Demonstrable experience of leading teams preferred

This is a 12 Month Fixed Term contract opportunity

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. Learn more about CSL Seqirus.

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