Description
Responsibility
Co-ordination, implementation and active participation in the validation programme for all business computer systems. Lead small team of computer validation specialists.
*Conduct validation activities in compliance with US and EU regulations, and global corporate procedures.
*Provide input into all project phases ie from design through to the commissioning and qualification execution phases of the project.
*Develop validation documentation as required
*Review and approve documents prepared by the validation team, other functional departments and contractors.
*Execute qualification protocols as required
*Prioritise qualification activities in line with the project schedules and business needs.
*Prepare reports of executed protocols
*Resolve and assist in the closure of deviations initiated during qualification execution
*Initiate and implement change control activities.
*Co-ordinate re-validation activities
*Generate SOP's/other documentation as applicable
*Conduct training in validation methodologies and related procedures as required.
*Present validation systems at internal and external audits
*Support quality assurance programmes
Skills & Qualifications
*Relevant 3rd Level Qualification in science or engineering.
* IT validation experience in an established QA function in the pharma industry.
*Strong knowledge of CSV/GAMP, 21CFR Part 11,Project Life Cycle and GMP Regulations.
*Validation experience of GAMP 5 systems would be an advantage
*Strong statistical skills and process capability are required along with excellent interpersonal, communication, facilitation and team working skills.
*Adaptable and flexible.