Urgent Requirement :: CSV Lead - Northbrook, IL.

[ajit rathore]

*NEED VISA COPY AND PASSPORT COPY.*



Hi,

Hope you are doing great!!



*Job Title : CSV Lead*

*Location : Northbrook, IL*



*START DATE : NEXT WEEK*





*JOB DESCRIPTION*



1. Lead the Computer Validation activities within a project with medium to
high complexity.
2. Responsible for creating, managing, and/or maintaining the documents
required for the development and validation of the computerized system.
a) Create and review all validation documents in the project.
? Authors Validation Plan, Training Plan, Issues Log, Design Review, IQ
Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test
Incidents, Trace Matrix, and Validation report.
? Reviews Functional Specifications, Design Specifications, User Manuals,
System Procedures, System Description and Training records.
b) Creates or contributes to the Supplier Audit Report, if required.
c) Contributes to or gathers CSV metrics for reporting purposes.
3. Oversight of protocol execution
a) Manages the overall protocol execution process, including resource
management, scheduling/timeline management, incident management, and status
reporting.
4. Prepares documentation within a validation package per policy and
procedure to support the validation of an application/system.
5. May participate in the development of internal CSV training materials.
6. May indirectly manage Validation Analysts activities within a project.
7. Leads or participates in CSV effectiveness and improvement initiatives.
8. Leads or participates in CSV knowledge development.
9. Co-ordinate between various sites for validation of Global Labeling
Platform
10. Devise Master Validation Plan in collaboration with all the responsible
project teams including documentation  of the scope, detailed time
estimation, work schedule and the documentation of assumptions and risks
11. Work with respective teams to determine regulatory requirements,
validation requirements, business & functional risks and ensure
documentation of the same
12. Design templates and checklists to monitor the progress of the project
and ensure that all the required information is captured and documented
13. Responsible for URS, FRS, Risk Assessment, IQ/OQ/PQ Testing and
Validation Summary Reports.



Regards

*Ajit Rathore*

*InfiCare **Technologies*| 22375 Broderick Drive #225 Dulles VA 20166 |

703-945-1834 Direct | *aj...@inficaretech.com *

*www.infiCareTech.com    *

Servicing our clients since 2001MBE/ DBE Certified in VA, MD, PA, NJ,
NC, CA

IT Services * Application Development * Mobility Solutions

-- 
You received this message because you are subscribed to the Google Groups "SAP 
Workflow" group.
To unsubscribe from this group and stop receiving emails from it, send an email 
to sap-workflow+unsubscr...@googlegroups.com.
To post to this group, send email to sap-workflow@googlegroups.com.
Visit this group at https://groups.google.com/group/sap-workflow.
For more options, visit https://groups.google.com/d/optout.

Urgent Requirement :: CSV Lead - Northbrook, IL.

[ajit rathore]

Hi,

Hope you are doing great!!



*Job Title : CSV Lead*

*Location : Northbrook, IL*



*START DATE : NEXT WEEK*





*JOB DESCRIPTION*



1. Lead the Computer Validation activities within a project with medium to
high complexity.
2. Responsible for creating, managing, and/or maintaining the documents
required for the development and validation of the computerized system.
a) Create and review all validation documents in the project.
? Authors Validation Plan, Training Plan, Issues Log, Design Review, IQ
Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test
Incidents, Trace Matrix, and Validation report.
? Reviews Functional Specifications, Design Specifications, User Manuals,
System Procedures, System Description and Training records.
b) Creates or contributes to the Supplier Audit Report, if required.
c) Contributes to or gathers CSV metrics for reporting purposes.
3. Oversight of protocol execution
a) Manages the overall protocol execution process, including resource
management, scheduling/timeline management, incident management, and status
reporting.
4. Prepares documentation within a validation package per policy and
procedure to support the validation of an application/system.
5. May participate in the development of internal CSV training materials.
6. May indirectly manage Validation Analysts activities within a project.
7. Leads or participates in CSV effectiveness and improvement initiatives.
8. Leads or participates in CSV knowledge development.
9. Co-ordinate between various sites for validation of Global Labeling
Platform
10. Devise Master Validation Plan in collaboration with all the responsible
project teams including documentation  of the scope, detailed time
estimation, work schedule and the documentation of assumptions and risks
11. Work with respective teams to determine regulatory requirements,
validation requirements, business & functional risks and ensure
documentation of the same
12. Design templates and checklists to monitor the progress of the project
and ensure that all the required information is captured and documented
13. Responsible for URS, FRS, Risk Assessment, IQ/OQ/PQ Testing and
Validation Summary Reports.



Regards

*Ajit Rathore*

*InfiCare **Technologies*| 22375 Broderick Drive #225 Dulles VA 20166 |

703-945-1834 Direct | *aj...@inficaretech.com *

*www.infiCareTech.com    *

Servicing our clients since 2001MBE/ DBE Certified in VA, MD, PA, NJ,
NC, CA

IT Services * Application Development * Mobility Solutions

-- 
You received this message because you are subscribed to the Google Groups "SAP 
Workflow" group.
To unsubscribe from this group and stop receiving emails from it, send an email 
to sap-workflow+unsubscr...@googlegroups.com.
To post to this group, send email to sap-workflow@googlegroups.com.
Visit this group at https://groups.google.com/group/sap-workflow.
For more options, visit https://groups.google.com/d/optout.