Execute and support the full computer system validation lifecycle, including planning, testing, implementation, and periodic review activities.
Develop, review, and maintain validation documentation such as Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
Collaborate with Quality, IT, Engineering, and Operations teams to ensure systems comply with GxP, FDA 21 CFR Part 11, Annex 11, and company quality standards.
Lead validation activities for new system implementations, upgrades, and infrastructure changes across manufacturing, laboratory, and business systems.
Investigate and assess deviations, incidents, and change controls to determine validation impact and ensure continued compliance.
Support internal audits and regulatory inspections by providing validation documentation and subject matter expertise as require
Responsibilities
Execute and support the full computer system validation lifecycle, including planning, testing, implementation, and periodic review activities.
Develop, review, and maintain validation documentation such as Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
Collaborate with Quality, IT, Engineering, and Operations teams to ensure systems comply with GxP, FDA 21 CFR Part 11, Annex 11, and company quality standards.
Lead validation activities for new system implementations, upgrades, and infrastructure changes across manufacturing, laboratory, and business systems.
Investigate and assess deviations, incidents, and change controls to determine validation impact and ensure continued compliance.
Support internal audits and regulatory inspections by providing validation documentation and subject matter expertise as require
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