James Wuerzer

Background

About James Wuerzer

11+ years’ experience in the Pharma/BioPharma industry working on validation projects to establish technically and scientifically sound protocols and test plans and to execute the protocols through preapproved testing. Qualified with a B.Sc. in Medical Biochemistry and experienced in demonstrating technical expertise for manufacturing troubleshooting, and in performing gap assessments and remediation as required on legacy qualification and validation packages. Skilled in reviewing technical documentation such as batch records, SOPs, preventative maintenance work orders, protocols, reports, control strategies, risk assessments for continuity and accuracy while ensuring project documentation is complete, accurate and in compliance with regulations. Hands-on experience in investigation and root cause analysis for incidents reported on validated systems and in coordinating successful execution of projects by working effectively with cross-functional groups. Adept at creating efficient and effective team working environments to deliver high quality results for stakeholders, new solutions and best practices. Involvement in successful MHRA and FDA audit inspections at previous site, presenting both Process and Cleaning validation documentation and procedures, receiving high praise for the systems in place and the updates that I had introduced. My core competencies are as follows: Process and Cleaning Validation Establishing Protocols Project Documentation Risk Assessments and Control Data Analysis Reporting Compliance Management Personnel Management Teamwork and Coordination Project Coordination Gap Assessments Stakeholder Liaising