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I am working with a mid-sized pharmaceutical company based in Berkshire that is seeking a Supplier Assurance Specialist to join their high-performing Global Quality team.
The role involves managing and maintaining the company's quality system to ensure quality assurance and regulatory compliance, adhering to relevant legislation and industry best practices.
The ideal candidate will have experience in:
* Managing suppliers and service providers across manufacturing, automated packaging, and distribution activities throughout Europe.
* Supporting other functions within the Global Product Quality team, including:
* Supporting the Quality Control Laboratory
* Conducting batch record reviews
* Managing, monitoring, reviewing, and approving Change Controls, Deviations, CAPAs, and PQCs
* Conducting training sessions on Quality processes
* Supporting regulatory inspections
* Artwork approvals
* Serialization solutions related to the Falsified Medicines Directive
Functional & Technical Competencies include:
* High attention to detail
* Excellent written and spoken English
* Proactive issue identification and resolution skills
* Experience managing GMP/GDP Quality Management Systems
* Additional relevant QA experience
* Strong communication skills
* Ability to learn and adapt quickly
* Ability to meet tight deadlines
* Handling sensitivity and confidentiality appropriately
* Negotiation skills with third parties on Quality processes
* Based at the European office with significant travel within Europe, Asia, and North America.
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