IT Infrastructure QA/ CSV

Location: New York Area

Job Description

Our client a leader in the Pharma industry, is looking for a QA/ CSV consultant focused on IT infrastructure to tackle a large project at their Tarrytown site.

Primary Responsibilities
1.     Computer System Validation:
  • Provide guidance to Project teams including project manager on Computer System Validation process.
  • Utilize knowledge of Software Development Life Cycle (SDLC) to provide input into Project Plan/schedule
  • Determining the documents needed to validate an IT application.
  • Draft high quality documents, such as Validation Plan/Test Plans/Protocols and or verify quality of documents produced by IT teams
  • Prescribe the level of documentation according to size and risk of a project (Right sizing documentation).
  • Liaise between the IT and QA teams and bridge the knowledge gap on both sides.
  • Prescribe and verify rigor of qualification and verification performed by the IT and business teams
  • Facilitate risk assessments utilize knowledgeable of Data Integrity, confidentiality and authenticity,  IT Security and Data privacy principles.
Secondary Responsibilities
1.     Change Request/Control Process:
  • Draft change requests, by gathering appropriate information from IT teams, structuring and rewording information in simple to understand verbiage.
  • Liaise between IT and QA Change Control Teams
  • Understand and document impact and risk of implementing change, and verify mitigation techniques adequately address risk.
  • Identify evidence needed to document and successfully execute change.
  • Manage Change Request life cycle i.e. authoring -> approval -> closure and all steps in between.
2.     Deviation Management:
  • Author deviations, by gathering information from IT teams, structuring information in simple to understand verbiage.
  • Lead investigations, verify accuracy of the root cause
  • Assess impact and risk associated with the deviation
  • Document Corrective and Preventive Actions (CAPA)
  • Verify completion of Corrective and Preventive actions
  • Close Deviations
  • Manage Deviation life cycle i.e. Authoring -> Investigating ->  Preparing Report -> Closure.