Description
SUMMARY DESCRIPTION:This position is responsible for review and approval of computer validation activities in a GxP regulated environment, focused primarily on ERP. Will participate in the development of custom programs, as well as configurable off the shelf (COTS) systems. 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.
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 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 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.
EDUCATION:
B.S. in a science, computer science, or engineering discipline, 4+ years experience in a GxP environment, with 4+ years of experience in a computer validation function.
EXPERIENCE:
* Must possess a thorough understanding of GxPs, in addition to FDA and International requirements for computer validation and Part 11 requirements.
* Must possess a thorough understanding of current industry guidance, including GAMP 5
* Must have direct experience with computer validation and determining computer validation approach, including enterprise platforms systems as well as custom software projects.
* Must have ability to comprehend technical information related to computer software, computer and network hardware, and the associated regulatory requirements relating to them.
* Ability to present and defend validation data to a small group.
* Experience in ERP, LIMS, EDMS, CMMS, and MES are highly desired.
* Proficiency with MS Office applications (Word, Excel, Visio, Access, Project, Power Point).
To find out more about Real please visit www.realstaffing.com