CSV/ Change Management

Our Client, a leader in the pharmaceutical industry, is looking for a CSV/ Change management consultant for a long term project. 

  1. Change Request/Control Process:
  • Well versed in authoring change requests, by gathering appropriate information from IT teams, structuring and rewording information in simple to understand verbiage.
  • Able to liaise between IT and QA Teams
  • Ability to understand impact and risk of implementing change, and verify mitigation techniques adequately address risk.
  • Experienced in identifying analysis and documents needed to accurately document and successfully execute change.
  • Experienced in Change Request life cycle management, i.e. authoring -> approval -> closure and all steps in between. 

  1. Deviation Management Skills:
  • Experienced in authoring deviations, by gathering information from IT teams, structuring information in simple to understand verbiage.
  • Ability to lead investigations, verify accuracy of the root cause
  • Ability to calculate impact and risk associated with the deviation
  • Document Corrective and Preventive Actions (CAPA)
  • Verify completion of Corrective and Preventive actions
  • Close Deviations
  • Experienced in Deviation life cycle management, i.e. Authoring -> Investigating ->  Preparing Report -> Closure. 

  1. Computer System Validation Skills:
  • Well versed in SDLC process
  • Ability to guide Project teams including project manager on Computer System Validation process.
  • Well experienced in determining the documents needed to validate an IT application.
  • Ability to produce high quality documents and or verify quality of documents produced by IT teams
  • Ability to prescribe the level of documentation according to size and risk of a project (Right sizing documentation).
  • Ability to liaise between the IT and QA teams and bridge the knowledge gap on both sides.
  • Ability to prescribe and verify rigor of qualification and verification performed by the IT and business teams
  • Knowledgeable with Data Integrity, confidentiality and authenticity principles
  • Familiarity/basic understanding of IT Security and Data privacy principles and risks

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