QA Advisor - GLP Clinical Studies

• Quality Assurance Advisor
• Fordham, near Newmarket, Cambridgeshire
• Salary: Up to £26,000 depending on experience
• Quality-related experience from a GLP environment ESSENTIAL
• GCP knowledge PREFERABLE
• Experience in Research or Clinical testing ESSENTIAL
• Auditing experience ADVANTAGEOUS
• Own transport preferable due to rural location

Summary

This is the perfect role for an enthusiastic QA professional with experience gained in a GLP- or GCP-regulated clinical testing or research laboratory environment. Please note this is NOT a role for someone whose experience only comes from a routine analytical QC setting or GMP QA position. Lab-based research experience is ESSENTIAL.

The Company

A new and expanding Pharmaceutical service organisation, with 450 employees over 4 UK sites. You will join the Quality group that supports a range of activities across the site in Fordham, covering lab and office areas. The Fordham site specialises in a range of Bioanalytical and Biological services, including in vitro research and the testing of clinical trial samples. The facility employs around 150 people in modern, spacious buildings and the company prides itself on how it promotes individual career development, offers a flexible approach to working hours and encourages employees to take part in social activities to complement the job.

The Role

Working within the QA team, you will be responsible for ensuring GLP and GCP compliance across the site’s activities, covering all laboratories and offices and all processes including initial project plans, the handling of biological samples, lab analysis, processing of data and reports, and submission of documentation to regulatory authorities. A summary of your main duties is as follows:

• Conduct GCP / GLP study and process audits and monitor the status and reporting of studies
• Investigate deviations from study plans and SOPs
• Write and amend SOPs
• Provide training to staff across the site
• Act as a central QA contact for enquiries relating to quality systems and the in-house IT system

This is a varied and challenging position that requires the utmost attention to detail and excellent communication skills.

Benefits

In addition to a generous salary, the company offers 25 days’ holiday, a contributory pension scheme and, if needed, flexibility of working hours.

Experience

The successful applicants MUST have extensive QA experience from a GLP environment, with knowledge and understanding of the handling and processing of scientific samples. Ideally you will have a scientific degree, though this is not essential if you offer good QA experience. You must have a solid grasp of GLP and its associated documentation. Knowledge of GCP would be a strong advantage, as would tangible experience of auditing.

We are NOT looking for a GMP QA Officer or someone whose experience comes only from a routine / manufacturing environment. Research experience is essential.

You must be able to demonstrate specific examples of your attention to detail, diplomacy, assertiveness and ability to communicate with people at all levels.

Keywords:

Quality Assurance, QA, GLP, GXP, GCP, SOP Review, Audit, Continuous Improvement, Process Improvement, Investigation, Deviation, CAPA, Quality Officer, QA Scientist, QA Officer, Quality Management System, QMS

This is a permanent role