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