Validation & IT Auditor II

Join The CTI Team•Covington, KY

3d•Hybrid

About The Position

Review full computer system validation deliverables for regulated software, hardware, and laboratory instrumentation applications, including Validation Plans, User Requirements, User Acceptance Testing, Test Cases, Traceability Matrices and Validation Summary Reports. Conduct internal audits related to validated systems and IT processes. Escalate any unresolved observations to QA management. Conduct vendor audits of SaaS vendors to assess qualification status. Escalate any unresolved observations to QA management. Prepare and distribute audit reports, providing clear communication of audit observations of the relevant CTI leadership. Assist with review of auditee response plans for adequacy of corrective and preventive actions and follow through to effective resolution. Assist QA leadership team with review of non-conformance root causes and implementation of effective corrective actions related to IT processes, clinical systems and validation CAPAs. Assist with review, revision, and management of IT, validation and system related SOPs. Assist QA leadership team with validation improvement initiatives. Provide guidance as needed for risk assessments and/or ensuring procedural controls are in place to mitigate risk and maintain compliance. Assist with implementing tools and procedures to facilitate documentation and tracking of quality assurance validation audit activities. Maintain significant knowledge in global regulatory validation requirements to provide regulatory compliance guidance and quality improvement consult to internal functions; proactively maintain in-depth knowledge of 21 CFR Part 11 Compliance. Assist with preparing training materials related to global validation requirements. Assume administrator responsibilities for quality assurance electronic systems. Create new accounts and assign appropriate roles/access. Recommend changes to current processes to provide more effective use of the quality assurance electronic systems and take the lead to implement such changes. Prepare training materials and conducting training related to relevant QA topics for CTI staff. Create and format document templates & trackers. Work closely with QA leadership to learn and enhance Quality Assurance responsibilities.

Requirements

Bachelor’s degree in business administration or physical/life science
Documentation of exceptional performance in prior leadership role(s)
At least 4 years in CRO, pharmaceutical, clinical or related fields

Responsibilities

Review full computer system validation deliverables for regulated software, hardware, and laboratory instrumentation applications, including Validation Plans, User Requirements, User Acceptance Testing, Test Cases, Traceability Matrices and Validation Summary Reports
Conduct internal audits related to validated systems and IT processes
Escalate any unresolved observations to QA management
Conduct vendor audits of SaaS vendors to assess qualification status
Escalate any unresolved observations to QA management
Prepare and distribute audit reports, providing clear communication of audit observations of the relevant CTI leadership
Assist with review of auditee response plans for adequacy of corrective and preventive actions and follow through to effective resolution
Assist QA leadership team with review of non-conformance root causes and implementation of effective corrective actions related to IT processes, clinical systems and validation CAPAs
Assist with review, revision, and management of IT, validation and system related SOPs
Assist QA leadership team with validation improvement initiatives
Provide guidance as needed for risk assessments and/or ensuring procedural controls are in place to mitigate risk and maintain compliance
Assist with implementing tools and procedures to facilitate documentation and tracking of quality assurance validation audit activities
Maintain significant knowledge in global regulatory validation requirements to provide regulatory compliance guidance and quality improvement consult to internal functions; proactively maintain in-depth knowledge of 21 CFR Part 11 Compliance
Assist with preparing training materials related to global validation requirements
Assume administrator responsibilities for quality assurance electronic systems
Create new accounts and assign appropriate roles/access
Recommend changes to current processes to provide more effective use of the quality assurance electronic systems and take the lead to implement such changes
Prepare training materials and conducting training related to relevant QA topics for CTI staff
Create and format document templates & trackers
Work closely with QA leadership to learn and enhance Quality Assurance responsibilities