Quality Management Systems Administrator

Quality Management Systems Administrator - Biotechnology - Oxfordshire - £25,000 - £35,000

Role: Quality Management Systems Administrator

Field: Cell Regeneration/ Medical Device//Biomedical/Medical/Tissue Repair/ISO 13485/QMS/IT Systems

Reporting to: Quality and Regulatory Affairs Manager

Location: Milton Park - Oxfordshire

Salary: £25,000 - £35,000 (dependant on experience)

A leading Biotechnology organisation based in Oxfordshire are looking to appoint a Quality Management Systems Administrator.

The Role:

This is a critical role within the business with the aim of the successful post holder becoming a subject matter expert on the use of the Electronic Quality Management System to provide support to users of the system. The Quality Management Systems Administrator will train users to use the electronic system, take an active role in the development of its use and ensure the system is appropriately validated and maintained. The role will also provide support to Quality and Regulatory Affairs Manager to transfer Quality processes to the system and provide support to the ISO 13485 Quality System.

The Role:

• Maintain the Electronic Quality Management System, customising its use and implementing further development to make the needs of internal stakeholders
• Ensure the Quality Management System is fully compliant to support audit and inspections
• Responsible for improvements to system functionality, ensuring they have been appropriately validated prior to implementation
• Ensure the system is appropriately validated to ISO and regulatory requirements
• Monitor system performance providing data for review at management reviews meetings
• Provide guidance and support to colleagues on the use of the Electronic Quality Management System
• Providing systems training to staff and manage the training programs
• Compile documentation reviews ensuring configurational requirements meet company/industry standards

Requirements:

• IT/Engineering/Science degree or equivalent would be beneficial but not essential
• Excellent IT Skills
• Understanding of working within a quality environment and familiar with Quality System concepts and requirements including GLP, GMP and ISO e.g. experience 13485/9001
• Previous experience of managing an electronic Quality Management System would be advantageous
• If you have worked on MasterControl QMS system that would be advantageous but this is not essential

To apply please send across your updated CV or call Jerry Hayman to discuss the role further.

Vibe Recruit is acting as an Employment Agency in relation to this vacancy.