Computer system validation engineer
Senior Validation Engineer required to review the computer system Validation processes and procedures for the overall site, GxP Risk Management process and ensure that appropriate mitigation steps are implemented to meet current GxP regulations
The systems are as follows
Enterprise resource planning business system (ERP) SAP Business 1 .
QC Empower laboratory chromatography data management system. CDS.
Retrospective validation/Gap analysis of all other potential GxP computer systems on site.
Main Duties & Responsibilities:
Manage the computer system Validation process for the overall site.
Manage GxP Risk Management process and ensure that appropriate mitigation steps are implemented to meet current GxP regulations
Plan and manage the cGMP validation test and documentation phase of the implementation with risk analysis used to define critical GMP components to be validated
Prioritize qualification activities in line with the project schedules and business needs.
Develop templates as required for Validation documentation
Prepare reports of executed protocols for review.
Generate SOP's / other documentation as applicable
Manage all Validation documentation created from the process
Manage overall signature process for all documentation
Manage Validation change control on the project
Develop procedures and processes for the complete computer validated state lifcycle, Data Integrity, Audit Trail review, Disaster recovery etc.
Skills / Experience:
3 - 5 years in a Computerized Systems Validation role (CSV).
Excellent technical English verbal and written skills
CSV experience in an established QA/IT function preferably in the pharmaceutical/healthcare industry
Strong knowledge of GAMP5, CSV, Project Life Cycle and GxP Regulations
Experience drafting, reviewing and/or approving validation documentation VMP, URS, RA, IQ, OQ, PQ, UAT, SAT and VSRs.
Previous experience generating Risk Assessment Matrices for validation projects.
Experience in validating pharmaceutical CDS and ERP system computer/control systems a distinct advantage.
Excellent attention to detail, self-motivated and ability to work to tight or changing deadlines
Work with existing in-house validation team