Quality Assurance Lead Consultant

Quality Assurance Lead Consultant | W2 Contract | Initial Contract Until December 31, 2025We are seeking a skilled Quality Assurance Lead Consultant for a 12-month W2 contract to support a key project at a leading pharmaceutical company, with the potential for extension based on performance.This project involves replacing an existing filling line at the facility, including the removal of old equipment, installation of new equipment, and reconnection of facilities and utilities. Your role will be focused on managing change controls to ensure smooth transitions, allowing the CQV team to focus on equipment qualification.Key Responsibilities:Manage change control processes for equipment, facilities, and utilities during the line replacement project.Collaborate closely with Process Engineering and CQV teams to ensure alignment and efficiency.Oversee change control documentation and ensure compliance with GMP standards in a sterile/aseptic manufacturing environment.Key Areas of Focus:EquipmentUnscramblers, washers, Depyro tunnels, fillers, stoppers, RABs, capper, tray loaders.FacilitiesAirlocks, electrical/mechanical rooms, wet rooms, vial prep rooms.UtilitiesWFI, nitrogen, chilled water, floor drains, compressed air.Qualifications:Proven experience in managing change controls within a GMP, sterile, or aseptic manufacturing environment.Familiarity with the listed equipment and facilities.Experience with Trackwise preferred.This is a great opportunity to join a high-impact project with a leading organization. If you have the expertise to manage change controls in a complex manufacturing setting, apply today!Hamish CorsonSenior Business Manager | USA | GxP Contract Division+1 646 536 4736 (USA)HCorson@

Created: 2025-01-24