Description
SUMMARY DESCRIPTION:This position is responsible for review and approval of computer validation activities in a GxP regulated environment, focused primarily on ERP. Duties include ongoing evaluation and periodic review of existing validated computer systems; change control; and validation of new computer systems. Other responsibilities of this position include: generation of validation plans, review and approval of SDLC documents, generation of test scripts/protocols; review and approval of protocols, execution of protocols; review of execution work, generation of final report; final package review and approval, validation contractor management and other duties as assigned. The position may require minimal travel to perform software vendor audits
RESPONSIBILITIES:
* Developing validation plans for specific computer system implementation projects.
* Working closely with Information Technology ERP, Quality Assurance and system owners to effectively and efficiently implement new systems, system upgrades, or system modifications.
* Assisting with design of computer validation testing in coordination with BioMarin policy and procedures.
* Assist in development, implementation, and enforcement of computer validation policies and practices.
* Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will produce the most value
* Protocol, execution work, and final report review and approval.
* Protocol and documentation tracking, using LiveLink and MS Access.
* Participation in the change control program for modifications to qualified systems.
* Manage consultants to ensure that project timeline, budget, and quality are maintained
* Ability to present and defend validation data to a small group.
* Coordination between internal departments, including Manufacturing, Information Technology, Quality Control, Quality Assurance, Corporate Compliance, Facilities, Technical Operations and Research & Development and others.
To find out more about Real please visit www.realstaffing.com