· Senior Quality Assurance Advisor
· Newmarket, Cambridgeshire
· Salary: £26k - £36k depending on experience
· Quality-related experience from a GCP / GLP environment ESSENTIAL
· Experience in laboratory-based Research or Clinical testing ESSENTIAL
· Auditing experience PREFERABLE
· Own transport preferable due to rural location
Summary
The perfect role for an enthusiastic QA professional with experience gained in a GLP- and GCP-regulated clinical testing or research laboratory environment, who wants to develop within an Auditing function and interface at senior level between laboratory and project teams from a Quality perspective.
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 Newmarket, covering lab and office areas. The Newmarket site specialises in a range of Bioanalytical and Biological services, including in vitro research and the testing of clinical trial samples. This 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 of around 12 people, 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
· Host client audits and produce necessary documentation
· 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, flexible working hours.
Experience
The successful applicants MUST have extensive QA experience from a GCP and 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 GCP and GLP and associated documentation.
We are NOT looking for a GMP QA Advisor 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:
Senior Quality Assurance, QA, GLP, GXP, GCP, SOP Review, Huntingdon, Audit, Continuous Improvement, Process Improvement, Investigation, Deviation, CAPA, Quality Officer, QA Scientist, QA Officer, Quality Management System, QMS
This is a permanent role