Quality Manager & RP

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Working Hours: 08:00 - 17:00, Monday to Friday (40 hours per week)

An established company in the temperature-sensitive logistics sector is seeking a Quality Assurance Manager & Responsible Person. This organization is recognized for its dedication to quality, compliance, and advanced technology solutions. They specialize in temperature-controlled deliveries to healthcare facilities and provide homecare services to end patients.

The successful candidate will assist in the implementation and maintenance of the Quality Management System, ensuring adherence to ISO 9001 and ISO 13485 standards, as well as compliance with EU GDP guidelines. The ideal candidate should have extensive experience as a Responsible Person and Responsible Person for Import on a WDA license.

Key Responsibilities:

• Work with the quality assurance team to implement and maintain the Quality Management System according to GMP, GDP guidelines, and relevant standards.
• Ensure ongoing compliance with legal requirements, regulations, and documented policies.
• Promote a positive quality culture within the organization.
• Participate in Quality System Management Reviews by preparing inputs, attending meetings, and managing outputs.
• Host and support regulatory audits, conduct supplier audits, internal audits, and self-inspections, including preparing CAPA plans.

Requirements

Key Skills/Experience/Requirements:

• Strong understanding of GDP and ISO 9001 standards; knowledge of ISO 13485 is beneficial.
• Eligibility to become a GDP Responsible Person and Responsible Person for Import.
• Effective communication skills for handling internal and external customer queries.
• Excellent organizational skills with keen attention to detail.
• Proven people management skills; prior line management experience is advantageous.
• Flexibility in working hours and ability to travel within the UK monthly.
• Proficiency in Microsoft Office Suite, including Excel, PowerPoint, and Visio.

Benefits

• 28 days holiday building to 33 days in 6th full holiday year
• Company pension scheme with 5% company contribution
• Private healthcare
• 10% performance related bonus