Consent Decree Remediation Project

Challenge

Working in partnership with the client, SOW creation revealed the most urgent needs to be across CAPA, Complaints and Validation Engineering workstreams for the site. Not only did the client require a range of specialist technical expertise, they also needed a workforce that was experienced working with an on-site FDA presence. In addition, the pre-existing quality culture at the facility needed changing. The workforce needed to be technically competent, but also possess excellent communication skills and the motivation to work in such a challenging environment.

Consulting Services

Solution


Proclinical assigned a dedicated, multi-lingual resourcing team that leveraged pre-existing relationships and networks to provide fully-qualified workforce options. Bespoke Resource Plans were put into place that utilized unique sourcing and qualification methods to ensure the right personalities were hired along with the correct level of expertise. These solutions ensured that we had a workforce that was ready to take on the challenge for the duration of the project.

Outcome


Quality Compliance

Our Resources Plan was a huge success: 90% of resumes sent were interviewed.

Quality Compliance

Our qualification methods were also a success. 90% of offers were accepted.

Quality Compliance

Peak headcount was 33, with 16 still on the site over a year later to ensure continuity.

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