Our client, a IT Services and Consulting company, is looking for a Lab System Validation for their West Point, PA location. Requirements:

+ Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

+ Experience of CSV Validation in any one of the Lab systems is must.

+ Should worked in pharmaceutical domain and its related knowledge is must

+ Good communication and technical writing skills are a must

+ Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.

+ Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.

+ CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle. Ada...