CSA Validation Manager

• *Key responsibilities**

:

Primary requirement is EDP, CSV and Test Automation experience.

• Overall Responsible for computer system validation lifecycle of the projects in scope.
• Creation, review and follow up (as applicable) with the concerned stakeholders for the closure of all the required Validation Deliverables in the lifecycle.
• Responsible to drive all tasks related to change controls, either directly or by delegating some of the activities in accordance with what is documented in the Validation Plan of the application and/or the RAL.
• Responsible for project managing all change controls to exercise control over the application.
• Responsible for reporting the validation project status to customer management as per mutually agreed frequency.
• Responsible for providing the GxP and GCP guidance to the team.
• Responsible for review and approval of test objectives and test cases created/ updated by the offshore team.
• Moderator in problem solving activities and progress meetings related to validation & testing (manual and automation) activities.
• Responsible for maintaining an oversight on the vendor deliverables as per the validation lifecycle.
• Responsible to ensure that BI applications are always in an audit ready state and to provide support during audits and inspections.
• Deviation Management and Change Management in TRACKWISE.
• Reports any non compliances observed and ensures tracking CAPA’s assigned to closure.
• Perform all the responsibilities in line with relevant customer SOPs and SOW.
• Validation and Test Strategy for switching to AI
• *Desired Experience::**

Stakeholder management (must have)

Computer System Validation and SDLC expertise (must have)

Manual and Automation testing experience (must have)

Life Sciences and clinical trail management (must have)

Good clinical practices and GxP (must have)

EDP, TOSCA, Cypress experience (nice to have)

AI Validation and Data Analytics

• *Stakeholder system::**

Works closely with client product teams, project sponsor, CSV&C and process area leads, as well as with Client leads, as necessary to manage expectations

Works in coordination with stakeholders representing vendors, customer, IT, business, internal and with connected application stakeholders