Rofiat Ogunlade Email & Phone Number

Providing professional Computer systems validation, quality assurance, software testing and IT/CSV audit services in varied complex computerised systems across several platforms within validated and structured environments.Wealth of experience of IT and scientific management in projects principally within the Pharmaceutical and Life Sciences sector (Clinical research, Manufacturing, Pre-clinical) ensuring compliance with statutory regulations, guidances and company standards (e.g. Annex 11, GXP, 21 CFR Part 11, GAMP 5, PIC/S)

Kent

CSV expert working closely with business partners to ensure systems meet regulatory requirements utilising a risk-based approach to system validation within a pharmaceutical environment working to GAMP, GxP, 21 CFR Part 11, Annex 11 and Data Integrity Guidance.

Responsible for the identification, continuous development and execution of appropriate activities for compliance with Good Clinical Practice (GCP) regulations, with regard to the development and deployment of clinical trials hosted by the College’s central product, Oracle InForm™. Manage the team providing support to system testing of clinical trials under development, and to trials requiring upgrades. This includes development, review and approval of appropriate validation lifecycle activities and deliverables, supporting implementation, upgrade and ongoing maintenance of the core system applications, InForm and Central Designer, as well as the clinical trials hosted by InForm.

Stevenage, United Kingdom

Data Integrity Project Lead across all Analytical Laboratory SystemsProject Manager and Lead CSV Specialist for the Implementation of Temperature Monitoring SystemSDLC and CSV Lifecycle maintenance activities on existing Validation SystemsCSV Policy and Procedures development in compliance with Company QMS and Regulatory Requirements

My responsibilities include:*Management of IT and Computer Systems Quality Assurance*Conduct Internal and external audits of IT and CSV*Management of the QMS documentation and development/maintenance of CSV related SOPs and operating instructions*Continual process improvement of operational quality activities related to IT and CSV; assess non-compliance and implement/monitor CAPA to correct issues*Developing training and communication programmes relevant to CSV activities*Maintaining knowledge of applicable regulations and implementing updates accordingly*Raising awareness and implementing best practice approach to IT and CSV complaince

London, United Kingdom

• Providing technical assistance to the systems group regarding the development of interfaces and general technical issues• Participating in the development of system specifications and documentation as well as user testing of new enhancements and functionalities as well as reviewing associated procedures, training and documentation• Creating and maintaining CSV documentation and project specific guidelines as required by SOP• Reviewing and executing test cases; identifying and recording quality problems and making recommendations and providing solutions as appropriate

London, United Kingdom

Facilitating the smooth running of clinical trials on the ward. Ensuring data is collected with utmost integrity and quality. Ensuring safety of study volunteers is maintained at all times. Reporting adverseevents as required.

Leadership And Management Development, Organizational Leadership

Imperial college led in depth leadership training programme comprised of professional qualifications for management systems, support.

Bachelor'S Degree, Business Information Technology, First Class

O Levels, 9 A

Executive Mba, Business Administration And Management, General