When new instrumentation, a facility change, or a LIMS implementation puts your qualification program under review, I build and review IQ/OQ/PQ programs across plant, equipment, and laboratory scope.
I procured laboratory instruments and produced full life-cycle validation documentation, including system boundaries and classification, impact and risk assessments, URS, SRS, traceability matrix, and IOQ protocols and final reports. I also reviewed vendor-executed IOQ protocols, set up asset numbers and calibration cycles, and updated SOPs before new instruments were released to the labs.
I managed validation, calibration, qualification, and maintenance for all QC and R&D instrumentation, scheduling more than 100 instruments with the validation and calibration department, and reviewed and executed commissioning documents and IQ/OQ/PQs across the analytical instrument range.
I was responsible for IQ, OQ, and PQ, commissioning, and decommissioning of manufacturing equipment and analytical instruments, and for maintenance under the Validation Master Plan. I improved validation activities for production equipment maintenance and calibration.
At contract manufacturing sites I was responsible for commissioning manufacturing equipment and implemented visual lockout/tag-out instructions for the validation of all processing equipment.
A qualification program that satisfies both operational needs and regulatory expectations.