Quality Assurance Coordinator

Our client specialises in improving brain health through the application of digital technologies.

Established as a trusted partner to the global biopharma industry, providing technology-enabled Their neuroscience expertise in image data management and analysis provides specialist data analytics services, which are applied on some of the most important clinical trials in neuroscience, providing valuable insights to disease progression and patient safety, enabling our clients to make better-informed decisions earlier in the clinical development pathway.

They truly have a passionate, dedicated team, bringing together the essential skills needed to innovate and develop cutting-edge technologies, provide the support our customers need and enhance our service offering.

As their  team continues to grow they are now looking to hire a Quality Assurance Coordinator.

This is a great opportunity for a Quality professional to thrive in an engaging and fast-paced environment, to make a difference on an every day basis. You will be given support to enable you to grow with your challenges, and they pride ourselves to be a sociable and diverse bunch of people, who are all working together on one big mission: Improving brain health. Will you join them?

Here's an idea of what you will be doing:

The Quality Assurance Coordinator (QAC) will report to and support the Quality Assurance Manager (QAM) in ensuring  Quality Systems and Quality Culture are of a sufficient standard to enable regulatory compliance and to enhance business effectiveness.

Support the enhancement of their  Quality Culture and embedding this by carrying out duties requested by the QAM.

• The QAC will co-ordinate process and training reviews to enhance business effectiveness.
• Oversight and co-ordination of Quality Plans for the different functional areas.
• Identify those areas of quality processes that need to be improved and propose new ways to improve quality.
• Act as a Quality Ambassador internally and externally.

Internal reporting & Management Review

• The QAC will collate and provide metrics/KPI's to assist the QAM and all departments to monitor Quality Plans/Quality Objectives and performance.
• The QAC shall collate, review and compare information/documentation to input into the Management Review process and other business reviews to improve quality and consistency.

Deviation and CAPA management

• To develop, maintain and improve the Quality Assurance System to ensure Investigations, Corrections and CAPAs are tracked and closed effectively and on time.
• To assess potential observational CAPAs and ensure that all deviations are logged and tracked so the Quality function can evaluate and document the agreed resolution.
• To provide oversight and metrics for all RT Queues, as required.
• To assist with Quality Investigations as required as requested by the QAM.

Internal & External Audit

• Assist and conduct Internal/Supplier Audits as required
• Administer the Internal & Supplier audit plan and records.
• Supporting preparations and administration of Client Audits and Regulatory Agency Inspections as required.
• Act as a scribe during Inspections and Client Audits.

Document Control

• Ensuring electronic Document Management System (DMS) and Training Management System (TMS) are maintained and procedural updates occur by the periodic review date.
• Taking inputs from other functions, prepare draft  Management System documents and coordinate the appropriate approvals.
• Review draft procedures against regulatory requirements and to ensure these are streamlined where possible.

Training Compliance and Delivery

• Ensuring training is documented and completed in good time.
• To ensure training records are available for audits and inspections.
• Provide GCP and ISO QMS expertise, guidance and training as required.
• Provide training for staff.
• Maintain awareness and understanding of applicable policies and procedures as defined in the employee training plan: including but not limited to IXICO's Quality Policy, Information Security Policy, Personal Information Management System Policy; ensure awareness of responsibilities under  policies and