Regional Regulatory Compliance Officer
IBM
- London
- 26,000-27,999 per annum
- March 22, 2019
- Permanent
About the Job:
The Regional Regulatory Compliance Officer is responsible for performing quality assurance activities as directed by the Global Regulatory Compliance Officer on life science industry accounts. He/she works with the account team members to assure GTS services are delivered in a compliant, efficient, and consistent manner to meet client needs. The Quality Assurance Auditor will conduct quality assurance reviews of project deliverables and operations from transition through steady state operations, evaluating compliance with the Life Science Industry Quality Management System.As assigned the Regional Regulatory Compliance Officer will conduct quality assurance reviews of account system specific documentation to include, but not limited to:
• Project Qualification/Validation Plans (QP/VP)
• System Requirement Specifications (SRS) • System Configuration Specification (SCS)
• IQ/OQ/PQ/UAT Qualification Test Plans
• Test Scripts
• SOPs
• Qualification/Validation Summary Reports (QSR/VSR)
As assigned the Regional Regulatory Compliance Officer will conduct quality assurance reviews of account operations to include, but not limited to:
• Personnel training records, CVs, and Job Descriptions
• Change Control • Corrective and Preventative Actions (CAPA)
• Standard Operating Procedures (SOPs)
• Records archival
• Provide concise communication of noted quality assurance and regulatory compliance issues to the Quality Assurance Supervisor/Manager
• Assist with the collection and reporting of designated account/project metrics
• Maintain a working relationship with account project and delivery team members to assure that compliance operations are aligned with business objectives and client expectations
• Maintain an up-to-date knowledge of life science industry regulations, quality assurance practices, infrastructure qualification and computerized system validation practices and procedures
• Perform all other related duties as assigned.
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