Phillip Harris Email & Phone Number

Wilmington, Oh

Full List of Job Activities• Review and Approval of GMP documents: SOPs, Batch Records, Validation Protocols, Change Controls, etc.• Review and Approval of Deviation Investigations for QC, Facilities, Metrology, Engineering, and Production deciding product impact, root cause analysis, and appropriate CAPAs• Mentoring of QA Associates including distribution of workload and explaining finer points of quality: root cause/capa relationship; risk based approach to quality; • QA Lead for Startup of New Production Lines• Regulatory Inspection support and assistance with response follow-up• Performance of Internal Audits and Supplier Audits• Six Sigma Project Facilitation and Execution• Metrics Reporting• Supervision of Third Party Manufacturing Activities• Recall Event Coordination and Documentation• Authoring of Annual Product Review

Greater St. Louis Area

• Review and Approval of GMP documents (SOPs, Stability Protocols and Change Controls) for Clinical and Commercial Production facility.• Review and Approval of deviation investigations regarding QC, Facility, Metrology, Engineering and Production deciding product impact, and appropriate CAPAs• Train personnel on CAPA and deviation investigation procedures• Member of CAPA Effectiveness Team, Change Control Task Force Team, Trackwise Re-Development and Implementation Team• Batch Disposition duties i.e. comprehensive investigation reviews• Revision of CAPA and deviation investigation procedures• Assistance with Audits (Scribing and Audit Response Team)

Dublin, Ireland

• Review and Approval of GMP documents (SOPs, Validation Protocols, and Change Controls) for Start-Up facility.• Chairperson for various Change Control Committees (Laboratory and Production)• Train personnel on procedures relevant to Change Control• Perform Gap assessments between Corporate Policies and Departmental SOPs• Reporting of Performance Metrics• Member of Automated Change Control Tracking System (Trackwise) Implementation Team

Greater St. Louis Area

• Review deviation investigations regarding QC and Productions issues for content, determination of product impact, and CAPAs• Facilitation of Raw Material Change Control meetings• Train personnel on deviation investigation procedures • Review and Disposition of Quality Batch Records• Handling of deviations related to validation protocols• Project work for start-up facility in Dublin, Ireland

Kalamazoo, Michigan Area

• Perform complaint investigations regarding prescription and over the counter medications• Facilitation of weekly staff meetings• Communication with manufacturing personnel regarding quality issues

Kalamazoo, Michigan Area

• Perform assays using Chromatography and Spectroscopy instruments• Conduct scheduled maintenance• Technical Writing of R&D analysis• Authoring Lab Analyst Training Program

Bachelor Of Science, Chemistry - Major And Mathematics - Minor

Activities and Societies: Chemistry Club

Six Sigma Black Belt

Xavier Consulting Group Certifications Project Management Six Sigma Black Belt