Our client, a global Health, Hygiene and Home company is looking for a Computer Systems Validation Professional to work with a recently placed Project Manager. This person will be responsible to ensure all CSV related requirements are captured and activities completed for the go live.

Position Responsibilities:

Candidate will be required to drive and own the end to end CSV activities.
This includes:

  • Preparing and owning the validation plan
  • Capturing CSV requirements and ensuring that testing scripts, etc meet validation requirements
  • Preparing the validation report
  • Ensure GxP requirements are in line with regards to the JDA WMS implementation for LA and St Peters, in accordance with governance standards and applicable government regulations
  • To provide documented evidence that can be used as part of a Computer System Validation package in the event of inspection by regulatory authorities and internal Audit

Below is a snapshot of the expected deliverables:

1.1.  Planning
1.1.1.Review CSV related assessments for impact
1.1.2.Author Validation Plan

1.2.  Specification
1.2.1.Review functional risk assessments or FMEA for CSV impact
1.2.2.Review and advise on Testing Scripts based on approved requirements, prior to execution

1.3.  Verification
1.3.1.Author Test Plan
1.3.2.Review executed Testing Evidence for completeness
1.3.3.Author RTM – mapping of requirements to evidence

1.4.  Reporting
1.4.1.Author Test Report
1.4.2.Author Validation Report

1.5.  Training
1.5.1.CSV Training
1.5.2.Good Documentation Practices

Location
Based in Parsippany, NJ

Length
8 months with possible transition to new projects.

To inquire about this position please email. stew.smith@bmtcorp.com