Salary: 20000.00-23000.00 British Pound . GBP (Annual)
Alere Toxicology is a provider of drugs of abuse laboratory testing services, and also a manufacturer of in-vitro diagnostic medical devices.
We are currently looking to recruit a Quality Compliance Administrator, based at our facility in Abingdon, to support the QA/RA department and the organisation's Quality Management System processes.
We are looking for a Quality Compliance Administrator to join our team here in Abingdon. Supported by the wider Quality Assurance and Regulatory Affairs team, you will play a key role in ensuring that all aspects of the quality system run smoothly and are in compliance with internal processes. You will report to the Head of QA/RA and your duties will be providing administration support for the following activities:
• Document Control
o Reviewing procedures for compliance to document control requirements
o Ensuring periodic review of documents are performed in a timely manner
o Managing controlled copies of documents within the business
o Cancellation and removal of obsoleted documentation
o Administering user accounts for the electronic document management
• Corrective and Preventive Action (CAPA) process
o Monitoring and tracking of CAPA progression and closure
o Reviewing CAPAs for compliance to internal procedure
• Non-conformance / Deviations
o Monitoring and tracking of quality incidents progression and closure
o Reviewing incidents for compliance to internal procedure
• Change Management
o Reviewing change control documentation to ensure compliance to internal
o Controlling the release of documentation linked to change controls
o Monitoring and tracking of change control progression to ensure timely
o Managing the assignment of mandatory training for new starters
o Liaising with other departments to ensure that departmental training is
being managed in accordance with internal procedure
• Product Registrations
o Requesting certificates of free sale and document notarisations to support
international registrations of Alere Toxicology products
Who are we looking for?
The successful candidate will have excellent attention to detail and strong organisational skills. The ability to communicate well with team members from all areas of the business is very important.
No prior experience in a quality assurance or regulatory affairs role is required, although it would be beneficial. Experience in an administrative role would be highly desirable.
Experience in, or an understanding of the laboratory testing or medical device industry would be advantageous.
Skills and Experience Required
• Computer literate
• Excellent communicator both face to face and email
• Proficient Administrator
• Organised and focussed under pressure
Start Date: ASAP