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Computer Systems Validation Specialist with Cell Therapy Experience

Company: Alpha Consulting Corp.
Location: Princeton
Posted on: January 15, 2022

Job Description:


Required Skills:
Experience leading CSV efforts and not just testing experience.
Strong testing experience with broader knowledge of CSV .
Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
Advanced knowledge of complete MS Office suite.
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.
Ability to work independently on CSV projects with minimal oversight.
Ability to perform in a highly matrixed organization structure.
Must Haves:
Good communication skills .
Strong knowledge on Cell therapy .
3-5 years of CSV lead experience .
3-5 years of HP ALM .
3-5 years of CSV Documentation author and review, approve .
1-2 years of experience in Change Control .
Should be able to work with minimal supervision .

Project Description:
This role will be responsible to guide project teams through validation process, perform regulatory risk assessments, author, and review and approve validation documentation, change requests and testing. They will work closely with the application test teams to ensure quality of validation deliverables and testing.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 advice 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.

Keywords: Alpha Consulting Corp., Trenton , Computer Systems Validation Specialist with Cell Therapy Experience, IT / Software / Systems , Princeton, New Jersey

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