Validation of oracle argus safety and oracle empirica signal for global pharma companies.

Training end users on the functionality of above mentioned applications.

Drafting of Project related documentation from VMP till Project closure documents.

Handling support related aspects and managing team to address issues in time.

• Responsible in drafting Project documents (VMP, SRS, RMR, OQ Plan, PQ Plan and RTM) and sharing the same with client.
• Managing and supporting project team in drafting Validation Scripts and look forward for smooth flow of the project.
• Conducting Steering Committee meetings every 2 weeks with stakeholders to update on the completed tasks, current status of the project and pending project tasks.
• Delegating Project tasks based on team member’s skill sets, experience levels and Monitoring to ensure the completion of all project activities in time.
• Active role in looking after the Validation of Oracle Argus Safety for Gemvax & KAEL hosted in Oracle Cloud post Upgrade activity.
• Assisting client in signing all the planning documents and Validation documents by providing clarifications with all the planning and validation documents.
• Assisting End Users in getting acquainted with Argus application.
• Participating in weekly meetings to update the Project status.
• Supporting the client with Application functionality.

• Develop Project Plan with the help of WBS to monitor, track progress and ensure project is in line with scope meeting timelines specified.
• Actively participated in drafting the validation scripts and Validation documents (OQP, OQR, PQP, PQR, RTM) based on the application functionality.
• Executing Validation scripts to validate system functionality.
• End User Training for client resources to understand application functionality.

• Active role in looking after the Validation and Migration of Oracle Argus Safety for client hosted in Oracle Cloud.
• Actively participated in drafting all the Planning documents, Validation documents, verifying the drafted validation scripts and assisting the team in execution of validation scripts.
• Participating in weekly meetings to update the Project status.
• Responsible in managing Migration activities involving drafting of Migration Qualification scripts, Post Migration Testing in validation and Production environment.
• Assisting client in signing all the planning documents and Validation documents by providing clarifications with all the planning, validation and project closure documents.
• Managing a team of 3 members to draft Validation scripts and test the application post migration in Test and Development environments.
• End User Training with the functionality of Argus Safety.
• Supporting the client with Application functionality.

• Continuous interaction with ARISg team to understand the issues with ARISg application post migration.
• Drafting UAT scripts to check the functionality and finalize those issues with ARISg application are fixed post migration from AERS to ARISg.
• Review the functionality of the application as per Pharmaceutical client’s requirement.
• Guided team of 3 people in successful drafting of validation scripts.