Description
Our client is a leading biotechnology company operating globally.They are currently preparing their extensive biotech site in France for upcoming Inspection in 2017 and require additional expertise in their readiness efforts.
They require 2 x CSV Engineer's for an initial 6 month contract to conduct an initial GAP analysis on the computer Systems across their process equipment and laboratory equipment.
Upon completion of the GAP analysis, the consultant will be responsible for cataloguing and closing all identified GAPS and implementing all necessary actions.
Requirements
- Experience in Computer Systems Validation in an FDA regulated environment is preferred
- Experience in Pre Audit Inspection projects
- Completion of GAP Analysis
- Experience in Data Integrity programs
- Knowledge of 21 CFR Part 11
- Knowledge and experience working with GAMP5 guidelines for computer systems validation
- Past experience in writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ,PQ, Risk Assessments, Requirement Specifications, RTM, Summary Reports)
- Experience in validating one or more of the following types of systems is desirable: Chromatography Data Systems, UV Probe, TOC, Analytical Lab Instrument Software
- Bachelors degree preferred in Computer Science/IT, Engineering or related discipline and experience in a computer systems validation role
- Proficiency with MS Office Tools
- Documentation Management
- Experience working with the following is desirable but not essential; Chromatography columns, bioreactors, ultrafiltration diafiltration, buffer prep, media prep, HPLC, UV, analytical equipment, Gas chromatography, laminar flow cabinets etc.