QA Associate - Maidenhead, United Kingdom - Seqirus
Description
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 prerelease 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 incountry distribution temperature excursion assessments, manage incountry provider nonconformances and perform return dispositions.
- Collation and assessment of KPI and metrics in support of Quality Management Review and Product Quality Review reporting and incountry 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 incountry 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 temperaturecontrolled 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.
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
:
**Watch our 'On the Front Line' video to learn more about CSL Seqirus
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