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IT Quality Validation Consultant

IT Quality Validation Consultant

Job Description

IT Quality Validation Consultant

Our direct client is seeking An IT Quality Validation consultant for a six ( 6) plus month opportunity with our direct client located in Northern, NJ (Montvale/Woodcliff Lake area) . Candidates must have the ability and desire to interview on-site with our client to be considered for the role.

Seeking computer validation for IT projects in pharmaceutical R&D systems. Focus will be on facilitating SDLC tasks and deliverables for GxP and non-GxP systems. Initial tasks will include SDLC documentation process improvement coordinated by client's IT Quality Services.

Works with various project teams on topics such as:
Assists with defining SDLC tasks and appropriate documentation for executionv of those tasks
Work with Quality Services to improve SDLC documentation processes
Determines an appropriate level of detail for tasks and documentation for projects
Scales the level of tasks and deliverables for infrastructure, on-premises applications, and hosted systems
Leads users through defining testable requirements
Leads users and project members through the risk assessment process for requirements and testing
Facilitates the preparation and execution of test cases
Manages the discrepancy and deviation process for projects and testing
Confirms SDLC training for team members and determine where additional training is needed
Evaluates supplier validation documentation for good documentation practices
Communicates difficult / sensitive information tactfully
Resolves and/or escalates issues in a timely manner

Coordinates with client's IT Quality Services and user Quality Assurance representatives to ensure client's quality expectations are being met.

The successful candidate will have a broad range of experience with validation expectations of US FDA GxPs, EU Annex 11, Japan PMDA, and PIC/S.

Job Requirements

Minimum- Bachelors Degree
7+ years Pharmaceutical or CRO industry experience with clinical/safety systems as well as experience developing and implementing the validation process and validation deliverables.
Past experience in Validating pharmaceutical R&D systems.
Hands-on experience facilitating SDLC tasks and deliverables for GxP and non-GxP systems

Job Snapshot

Employment Type Contractor
Job Type Information Technology, Consultant
Education 4 Year Degree
Experience At least 7 year(s)
Manages Others No
Industry Pharmaceutical
Required Travel Not Specified
Job ID FA14-00262
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IT Quality Validation Consultant

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