Lucas User

As a seasoned Document Controller with 13 years of experience in the Pharmaceutical Industry, I have a proven track record of streamlining procedures and mentoring team members on document workflows, Batch Record review, Quality Assurance, and Clinical Trials. With a strong background in GMP, GDP, GCP, CAPA, SOP, QMS, DMS, TMF, and GxP, I excel in leading Clinical Trials projects and providing expert advice to stakeholders engaged in the review and approval of project documentation.

I possess excellent computer skills, including proficiency in MS Office, Q-Pulse, M-Files, Adobe Pro, Excel, Databases, Cloud Storing, SharePoint, and SAP knowledge. My strong people skills, negotiation skills, and proactive thinking enable me to develop strong customer relationships and ensure accurate and efficient quality checks and review of GMP documentation related to batch release.

With a strong educational background in English Language and Literature, I am a driven individual offering positivity and relative ease in tackling GMP documentation tasks and leading Clinical Trials projects.