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.
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.
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.