Our client, a leading pharmaceutical company, is hiring a Commissioning/Qualification/Specific Commissioning and Validation Support on a contract basis.
– Participate as part of a cross functional global project to qualify QC instruments and associated software
– Create, execute, and review network-led QC instrument/software qualification documents in support of global QC projects
– Support the implementation of a standardized global qualification for QC instrumentation and associated software across multiple client QC sites
– Author qualification related deviations, identifying root causes and robust CAPAs
– Author qualification related change controls and validation plans
– Update client procedures and documents to implement data integrity controls arising from instrument qualification programs.
– Serve as liaison with lab-IT teams to harmonize QC instruments software configurations where applicable
– Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
– Provide updates on qualification status, project timelines, and escalate challenges as required.
– Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team.
– Support general QC asset management
– Coordinate/interface with vendors for servicing/maintenance/upgrades
– Execute periodic assessments/decommissioning as needed
Qualifications and Experience Required:
– Bachelors degree in relevant scientific or computer area with 7 – 10 years experience in the biopharmaceutical industry or MS degree with 6+ years experience or equivalent combination of education and experience.
– Minimum 6 years experience in a role either (a) QC instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
– Demonstrated expertise in large projects, prioritizing workload with minimal supervision
– Demonstrated ability to work independently as well as contribute to a team based collaborative environment
– Self-directed with a high degree of professional integrity, organization, and attention to detail.
– Strong interpersonal, oral, and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
– Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
– Ability to travel when required