Summary

• To monitor, analyse and bring to closure, quality records across Analytical Services.
• To contribute to department projects by collating data, defining actions and delivering improvements to processes based on quality gaps.
• The role is 37.5 hours and will be based in Slough, UK.
• This is a 12 month contact.

Job Description

• Lead quality records and assignees to a state of record closure and develop summaries to provide status updates for meetings.
• Accountable for the generation, analysis and presentation of the output of quality metrics weekly/monthly/annual review reports to the department and AS management.
• Deliver compliance projects for process improvements based on quality gaps.
• Liaise with the Training Specialist and lead development of training material to close gaps identified from quality records.

Requirements:

• The successful candidate will have laboratory based, scientific technical reviewing or auditing experience.
• Understanding of lab support functions and working knowledge of Trackwise and Document Management systems would be a distinct advantage.
• They will have proactive interaction with teams and will coordinate information across departments and teams. Research & analyse trends and patterns. Solutions driven.
• Capable of applying knowledge of regulatory guidelines from FDA, ISO9001, CFR 21 and ICH to laboratory observations.