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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP)

Location: United Kingdom

Supply Chain Quality Associate - Maidenhead, England - Permanent

Proclinical is seeking a dedicated QA Associate for our Supply Chain Quality Assurance team. This is a permanent position located in Maidenhead, England.

Primary Responsibilities:

The primary focus of this role is to work with internal and external stakeholders to ensure the timely release of finished products and uphold high standards of compliance for transportation, storage, and commercial distribution. The role also involves providing quality support to commercial affiliates and overseeing in-country distribution and Global Logistics providers, including Quality KPI and metrics reporting.

Skills & Requirements:

Ability to work with limited supervision and with multinational teams.
Excellent communication skills.
Understanding of Good Distribution Practice Guidelines for EU.
Ability to interpret product technical data in conjunction with written procedures to provide compliant product disposition decisions.
Ability to plan and appropriately prioritize activities to meet internal timelines.
Bachelor's Degree in Science is preferred.
Experience in a GxP environment with experience in Quality Assurance and of temperature-controlled shipments or storage of products is preferred.

The Supply Chain Quality Associate will:

Completion of pre-release checks in support of batch release for further distribution.
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.
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.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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