Vacancy expired!
Title: Validation Specialist Pay Rate: $60 to $70 Location: New Brunswick, New Jersey Contract Duration: 12 Months with possible extension. NOTE: No C2C only W2 Job Description: 6 plus years' experience 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, 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 Required: 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. Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. 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 (e.g. 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. Once trained, can work independently on CSV projects with minimal oversight. Ability to perform in a highly matrixed organization structure. Skills: Knowledgeable in CSV, GAMP, Electronic Records/Electronic Signature regulations, and related health authority regulations and guidelines: 0 to 2 years Strong oral and written communication skills including the ability to write superior documentation and deliver clear and articulate presentations: 0 to 2 years. Must Haves: 2 plus years of experience in managing the projects as CSV specialist. 2 plus years of experience in testing, (script reviewing from a QA perspective in particular) 2 plus years of experience in authoring, reviewing various validation documentation such as (Val plan, Risk assessments etc.) Good communication and writing skills. Knowledge of GAMP and 21 CFR Part 11 Pay Range: $60 - $70 The specific compensation for this position will be determined by several factors, including the scope, complexity, and location of the role as well as the cost of labor in the market; the skills, education, training, credentials, and experience of the candidate; and other conditions of employment. Our full-time consultants have access to benefits including medical, dental, vision as well as 401K contributions. #LI-MK3
- ID: #49969441
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State: New Jersey
Newbrunswick
08901
Newbrunswick
USA
- City: Newbrunswick
- Salary:
USD
TBD
TBD
- Job type: Permanent
- Showed: 2023-05-20
- Deadline: 2023-07-18
- Category: Et cetera