Req: Validation Engineer @ Ann Arbor, MI

Designation/Position Name Validation Engineer
Number of Vacancies 1
Client Name TERUMO CARDIOVASCULAR SYSTEMS CORP.
Rate : 50/hr c2c
Customer Interview Required (Yes/No) Yes
Duration of the Project 1 year
Job Title Validation Engineer
Positions based at Ann Arbor, Michigan

Job Description

Additional requirement
• Responsible for managing and executing the validation of non-product
software applications (including, but not limited to ERP System, PDM
system, CAPA Management system, Reports, Spreadsheets, MES system),
• Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part
11), guidelines and internal procedures related to validation of computer
systems, E&AS and associated infrastructure are followed and applied during
all stages of the defined software development life cycle (SDLC) and
project phase activities
• Creates validation and qualification deliverables, such as change impact
assessment, user and functional requirement specifications, data migration
plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new
software, enhancements, maintenance releases, and periodic reviews
• Analyzes the validation impact of changes and helps in formulating the
validation plan for changes to existing or new computer systems
• Identifies and coordinates activities and tasks required to complete
qualification and validation activities including reviews with Quality,
obtaining signature approvals, executing qualification protocol or
validation project plan, managing change control (change requests)
• Supports risk assessment and system lifecycle processes such as change
control and document management.

Positions based at Ann Arbor, Michigan

Key word to search

*Validation of Computer Systems, GAMP5, 21 CFR Part 820 & 21 CFR Part 11,
Installation Qualification (IQ), Operation Qualification (OQ) and
Performance Qualification (PQ), Validation Master Plan*
Job Description
1. Responsible for managing and executing the validation of non-product
software applications (including, but not limited to ERP System, PDM
system, CAPA Management system, Reports, Spreadsheets, MES system)
2. Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part
11), guidelines and internal procedures related to validation of computer
systems, E&AS and associated infrastructure are followed and applied during
all stages of the defined software development life cycle (SDLC) and
project phase activities
3. Creates validation and qualification deliverables, such as change impact
assessment, user and functional requirement specifications, data migration
plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new
software, enhancements, maintenance releases, and periodic reviews
4 Analyzes the validation impact of changes and helps in formulating the
validation plan for changes to existing or new computer systems
5 Identifies and coordinates activities and tasks required to complete
qualification and validation activities including reviews with Quality,
obtaining signature approvals, executing qualification protocol or
validation project plan, managing change control (change requests)
6 Supports risk assessment and system lifecycle processes such as change
control and document management.

Mandatory Skills



*FDA regulations 21 CFR Part 11, Part 820 GoodGAMP5 Knowledge *

*IQ,OQ,PQ, Validation Master Plan Risk Assessment Good User and Functional
Requirements specification Good*


-- 

*Thanks + Regards,*


*George,*


*347-815-4828, (email is PERFECT way to get quick response),*

*G talk / YIM/ Skype**: George.humanresource*

<http://www.linkedin.com/pub/george-l/63/557/59b>

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