Computer Systems Validation Specialist with Cell Therapy Experience
Company: Alpha Consulting Corp.
Posted on: January 15, 2022
COMPUTER SYSTEMS VALIDATION SPECIALIST WITH CELL THERAPY
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
Advanced knowledge of complete MS Office suite.
Firm understanding of technology platforms as needed for
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,
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
Ability to perform in a highly matrixed organization structure.
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 .
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
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
Independently assess compliance practices and recommend corrective
Approve validated computer system related change requests .
Monitor regulatory and inspection trends and advice the business on
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
Keywords: Alpha Consulting Corp., Trenton , Computer Systems Validation Specialist with Cell Therapy Experience, IT / Software / Systems , Princeton, New Jersey
Didn't find what you're looking for? Search again!