Beschreibung
Harvey Nash is looking for a Technical Writer for a 6 month project in Switzerland.
The role is for a Computer System Validation engineer/Technical writer to support rollout of an application solution.
You are responsible for
" Managing, co-ordinating, developing and executing the validation deliverables for a new IS project.
" Supporting and co-ordinating the qualification and validation processes
" Supporting activities including, but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
" Facilitating the release of the regulated system for GxP production use in line with project timelines; Supporting the resolution of project deviations/errors and providing quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
" defining test strategy, designing and developing test cases from software requirements, architecture designs, and code of complex software systems.
" Conducting validation training with project team communicating deliverables, procedures and methods
Requirements
" Bachelor's degree in Automation Engineering, Electrical Engineering, Systems Engineering, Technology or a related discipline.
" At least 3 years of industry experience in software engineering
" Software Validation and Equipment Validation experience in a regulated industry: FDA 21 CFR 820, the Quality System Regulation and ISO 13485.
" Experience of GxP Computerised Systems
" Understanding of GAMP5 Guidelines.
" Validation experience with ERP, CCMS/CMMS, and Quality Systems is preferred
" Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required
" Strong knowledge of computerized system development life cycle approach is required
Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.