Circle Lifesciences helped mitigate major roll-out risk with their Pop-Up Quality and Validation team
Validation Pop-Up Team
A large pharmaceutical client required additional support within their Quality and Validation Teams for their batch release lines. The client previously had MHRA audit inspections, which due to an under-resourced team, returned critical findings. The knock-on effect meant there was an immediate need for the correct individual to lead a remediation/deviation project.
After having an in-depth conversation with the Quality Director to identify exactly what they needed to turn their current position around, we both agreed it was not just one Quality, and one Validation contractor required but that it would be a specialist Pop up Team that could integrate immediately with the correct skillset.
After analysing the position of a contract Quality Manager – and precisely what the client needed – we were able to compile a candidate validation process to ensure the pop-up team could swiftly support the project with minimal risk.
After Identifying three correct candidates within 24 hours and arranging interviews, the client chose the most suitable contractor for the project and they were on site within one week.
From this, the Circle consultant, the contractor, and Quality director had daily calls and teams' meetings to pursue the pop-up team’s needs. We identified the need for Quality Assurance support, Quality Control Support, Qualified Persons, and a Validation Manager.
Briefs were taken for each position with a set time lines for each role. Within two weeks, we had a successful team of eight contractors on site covering all areas required to identify the root cause of the Audit findings and they began implementing a road map to success.
With pace and precision placing such a large team with the correct knowledge, skills and experience it was only right to have regular updates with the hiring managers and through doing so we managed the entire process with them, including the identification of any further needs or gaps.
The client is now firmly on the road to success with deviations being closed off and the preparation for new audits being firmly processed.
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