Vacancy expired!
BH: 3739126 MUST BE ABLE TO WORK ON AN EMPLOYEE BASIS NO C2C ONSITE Our Client is expanding and currently seeks a
VALIDATION SPECIALISTFor a 12+month assignment with possible extensions Could go direct LOCATION: East Syracuse, NYPosition is 100% ONSITE This role requires full vaccination against COVID-19 as a condition of assignment, Medical or religious accommodations will be considered on an individual basis Leverage your Validation skills to help take your career with our Client to the "Next Level" for 2022 and beyond! Our Client is seeking a Computer System Validation (CSV) Technical Lead to support their regulated business processes. Responsibilities: •Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes. •Follow SOPs and industry best practices. •Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. •Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system. •Review validation deliverables for projects which are contracted to third party suppliers. Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. •Assist in planning, implementing, and documenting user acceptance testing. • Review computerized systems validation documents such as: • Requirements Specification • Design Specification • CSV Risk Assessment • Test Plans • Test Summary Reports • Data Migration Plan • Pre/Post Executed Test Scripts • Traceability Matrix • Release to Production Statements Direct and review testing •Provide guidance on quality issues that affect the integrity of the data or the system. •Obtain and respond to QA review. •Participate in establishing standard quality and validation practices. •Independently assess compliance practices and recommend corrective actions. •Approve validated computer system related change requests. •Monitor regulatory and inspection trends and advise the business on suitable action. •Ability to create documents to an existing document standard. •Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries. Requirements: • Minimum of 3 years' experience in Computer System Validation. • Able to develop all documentation required for a 21 CFR Part 11 validated project, including configuration specifications, SOPs. • Experience with scientific laboratory software. • Advanced knowledge of complete MS Office suite and MS Windows 10. • Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (ServiceNow, SAP Solution Manager, etc.). • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. • Ability to perform in a highly matrixed organization structure. Education: 4 year degree mandatory. Important information:- There is no per diem with this position
- There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
- MUST be able to work without sponsorship or VISA transfer for this position.
Vacancy expired!