- 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
- Metrics in support of Quality Management Review and Product Quality Review reporting and in[1]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.
- Bachelor's degree in science is preferred
- 2-3 years in a GxP environment with experience in Quality Assurance and of temperature-controlled shipments or storage of products is preferred.
- Ability to work with limited supervision and within multinational teams speaking different languages. Ability to communicate at different levels within and external to the company is required.
- Experience working within GDP for EU is essential.
- Ability to interpret product technical data in conjunction with written procedures to provide compliant product disposition decisions.
- Ability to plan and appropriately prioritise activities to meet internal timelines is critical.
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QA Associate - Maidenhead, United Kingdom - CSL
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.
This position is based in Maidenhead
Responsibilities include: -
Qualifications, Skills and Experience
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives.
