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    Quality Leader- Supplier Assurance - Glasgow, United Kingdom - SRG

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    Pharmaceutical / Bio-tech
    Description

    SRG are excited to be working with a global name in the healthcare industry to help them find a Supplier Assurance Associate to join their QA team.

    This is a great opportunity for someone with good QA experience from a cGMP environment and will provide training and development.

    The Role:

    • Leading supplier quality visits for primary, secondary and tertiary component manufacturers and contract goods.
    • Dealing directly with supplier processes, validation of those processes and their quality standards
    • Management of Supplier Corrective Action Report Procedure
    • Manage Supplier score cards to ensure robust, risk-based processes for supplier scoping, approval and ongoing qualification to control and drive supplier continuous improvement.
    • Manage third part contract good release to market, ensuring compliance and timelines are met
    • Oversee the Vendor Approval System for API, excipient, packaging manufacturers, third party contract manufacturers and external service providers
    • Provide trending data & reports upon request to senior management, functional managers, regulatory authorities & customers
    • Lead on the investigation and Corrective & Preventative Actions relating to supplier Non Conformities including implementation and effectiveness checks
    • Documentation Owner for Supplier documentation including creation, document management and authorisation of Artwork
    • Act as an SME supporting inspections

    Requirements:

    • Degree in a relevant scientific discipline
    • Experience working within QA in a cGMP environment
    • Experience of supplier audits and/or vendor assurance would be beneficial
    • Excellent organisational and time management skills
    • Good knowledge of GMP and ISO regulations
    • Awareness of regulatory requirements


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