QA Batch Release Coordinator

3 weeks ago

Liverpool, United Kingdom Seqirus A CSL Company Full time

Reporting to the QA Batch Release Manager, the role of the QA Coordinator (Batch Release) is to provide technical leadership and to co-ordinate activities allocated to the team; specifically batch release activities related to Lot Release Protocol activities, batch shipment and release activities. To deputies for the manager. To manage organisational change and process improvements through development of a team. To coordinate and ensure that team goals are achieved and operational decisions are made and completed promptly. To ensure compliance with regulatory requirements, cGMP and company SOPs. To ensure that all scheduling requirements are met, together with other departments where required. To review and collate lot release protocols and batch release packs for batch release purposes. To bring to the attention of the team manager, and other site personnel, any issues which may affect batch release. Also, perform the required transactions to release materials and perform submission of Lot Release Protocols.
- To perform PTC /AE activities, to ensure root cause investigations are completed promptly and important items are escalated to management.
- To provide direction to the team and ensure that mandatory training is in place. To encourage performance of staff through training (LMS), feedback and development planning together with the manager. Promote positive change.
- To have an active involvement in site quality systems, deviations, change controls, SOPs, and self-inspections. Promote a cGMP compliant culture, ensuring the highest standards of Housekeeping and Safety are applied in the team, observing current regulations and procedures. To be permanently inspection ready, ensuring that the review, storage and archive of cGMP documentation and batch specific records is up to date and at the required standards.
- To deputies for the department manager, performing such tasks as may be reasonably required by management.
- To cross-train in activities which will allow contribution and support to activities in other QO departments, as needed by the business
- Education Requirements
- Graduate level in relevant discipline or suitable alternative or equivalent experience within industry
- Experience Requirements
- Proven experience working in a Batch Release/QA role
- Experience of Quality Assurance procedures and industry practices desirable

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


We want Seqirus to reflect the world around us

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