QA Associate

4 months ago

Maidenhead, United Kingdom Seqirus A CSL Company Full time

This position is responsible for working with internal and external stakeholders to ensure timely release of finished product and high standards of compliance for transportation, storage and commercial distribution. Provide Quality support to the commercial affiliates and oversight of in-country distribution and Global Logistics providers including Quality KPI and metrics reporting.

**Responsibilities**:

- Completion of pre-release checks in support of batch release for further distribution including review of temperature data and transportation documentation and serialisation checks following confirmation of technical release by batch release teams.
- Author in-country distribution temperature excursion assessments, manage in-country provider non-conformances and perform return dispositions.
- Collation and assessment of KPI and metrics in support of Quality Management Review and Product Quality Review reporting and in-country provider performance.
- Maintain oversight of commercial affiliate and Seqirus Global Logistics functions through regular review meetings.
- Ownership and QA approver for change control, deviation management, CAPA management and document control.
- Liaise with the Supplier Management function to complete initial and ongoing qualification activities for in-country distribution providers.
- Control of SAP master data for finished product distribution in collaboration with the Supply Chain function.

Qualifications:

- Degree in Science preferred or equivalent experience in the pharmaceutical industry.
- Proven exp in a GxP environment with experience in Quality Assurance and of temperature-controlled shipments or storage of products preferred.
- Proven GDP experience.
- QMS / Quality systems

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

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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