Head of Quality
4 weeks ago
Head of Quality – RP/RPInLocation: 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.nCritically 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 tasknPeople 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.nSetting quality KPI’s at sites in line with the UK and regional requirements.nGuarantee that the storage facilities and GXP systems are qualified in line with regulatory requirements.nEnsure that the Quality Management systems are implemented and maintained, and deviations/ CAPA/ complaints are effectively managed.nEnsure that the suppliers and customers are evaluated and approved, including subcontractor activities.nCoordination of any recall operation carried out by the organisation and/or assistance when one is initiated by MAH.nCustomer management, including complaints, trends, and continuous improvements.nMHRA inspections, ISO accreditations, and client audits.
RPI Duties, which includenSupply chain security.nConfirm 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.nImplement 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 profilenYou will be an experienced RP or RPI who has worked within the medical devices and pharmaceutical vertical.nTrained in the requirements laid down in the EU GDP Guideline and familiar with the GDP operations of the licence holder.nUnderstand the security of storage, traceability during storage, and onward distribution.nBe passionate about healthcare and patient safety, motivated and enthusiastic with an approachable mannernExcellent communication, both written and verbalnThe ability to build relationships quickly
What we offern25 days annual leave with the option to purchase up to an additional 5 daysnPension contributionnA life assurance policy that pays out 4 x SalarynEmployee Assistance Programme that provides you with confidential support, information, and advice to help younEmployee Discount Scheme through Treats
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