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Head of Quality

4 months ago

Co West Midlands, United Kingdom Arvato Full time

Job Description

Salary: c£75k + Car Allowance + Bonus

Role: Head of Quality – RP/RPI

Location: Kings Norton or East Midlands

Reporting to the Healthcare Director you will play a pivotal role in developing, implementing, and monitoring quality assurance processes, systems, and procedures to ensure Arvato conforms to all aspects of Quality within Pharmaceuticals and medical devices in line with regional and global requirements.

As a subject matter expert, you will be the point of contact for clients, customers, regulatory bodies, global quality colleagues, and internal teams, where you will provide guidance and support regarding Good Practice Distribution, ISO9001, and ISO13845 standards.

Critically you will be RP/RPI who is responsible for safeguarding employees against any potential hazards that may arise from poor distribution practices and upholding compliance to WDA

Your task

  • People management within the Quality streams and ensuring people are trained with systems and procedures to promote the development of the Quality team's knowledge in regulations and accreditations.
  • Setting quality KPI’s at sites in line with the UK and regional requirements.
  • Guarantee that the storage facilities and GXP systems are qualified in line with regulatory requirements.
  • Ensure that the Quality Management systems are implemented and maintained, and deviations/ CAPA/ complaints are effectively managed.
  • Ensure that the suppliers and customers are evaluated and approved, including subcontractor activities.
  • Coordination of any recall operation carried out by the organisation and/or assistance when one is initiated by MAH.
  • Customer management, including complaints, trends, and continuous improvements.
  • MHRA inspections, ISO accreditations, and client audits.

RPI Duties, which include

  • Supply chain security.
  • Confirm the status of unique identifiers for prescription-only medicines if required depending on if the material is destined for supply to Great Britain or Northern Ireland.
  • Implement and manage the system to confirm products that have been imported into Great Britain from countries on an approved ‘country for import’ list and verify that the required QP certification has taken place.

Your profile

  • You will be an experienced RP or RPI who has worked within the medical devices and pharmaceutical vertical.
  • Trained in the requirements laid down in the EU GDP Guideline and familiar with the GDP operations of the licence holder.
  • Understand the security of storage, traceability during storage, and onward distribution.
  • Be passionate about healthcare and patient safety, motivated and enthusiastic with an approachable manner
  • Excellent communication, both written and verbal
  • The ability to build relationships quickly

What we offer

  • 25 days annual leave with the option to purchase up to an additional 5 days
  • Pension contribution
  • A life assurance policy that pays out 4 x Salary
  • Employee Assistance Programme that provides you with confidential support, information, and advice to help you
  • Employee Discount Scheme through Treats
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