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Validation lead

In New Jersey / United States

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Validation lead   

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JOB TITLE:
Validation lead
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
Raritan New Jersey / United States

JOB DESCRIPTION :

Apply FDA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes

Follow SOPs and industry best practices

Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.

Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system

Review validation deliverables for projects

Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

Assist in planning, implementing, and documenting user acceptance testing

Review computerized systems validation documents such as:

Compliance Analysis

Compliance plan/report

Requirements Specification

Design Specification

CSV Risk Assessment

Test Plans

Test Summary Reports

Data Migration Plan/report

Pre/Post Executed Test Scripts

Traceability Matrix

Release to Production Statements

Direct and review testing

Provide guidance on quality issues that affect the integrity of the data or the system

Obtain and respond to QA review

Participate in establishing standard quality and validation practices

Independently assess compliance practices and recommend corrective actions

Approve validated computer system related change requests

Monitor regulatory and inspection trends and advise the business on suitable action

Ability to create documents to an existing document standard.

Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)

Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.

Once trained, have the ability to work independently on CSV projects with minimal oversight.

Ability to perform in a highly matrixed organization structure

Position Details

Apr 17, 2021
S16174659510821803
New Jersey / United States
Raritan
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Validation lead    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Apply FDA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes

Follow SOPs and industry best practices

Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.

Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system

Review validation deliverables for projects

Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

Assist in planning, implementing, and documenting user acceptance testing

Review computerized systems validation documents such as:

Compliance Analysis

Compliance plan/report

Requirements Specification

Design Specification

CSV Risk Assessment

Test Plans

Test Summary Reports

Data Migration Plan/report

Pre/Post Executed Test Scripts

Traceability Matrix

Release to Production Statements

Direct and review testing

Provide guidance on quality issues that affect the integrity of the data or the system

Obtain and respond to QA review

Participate in establishing standard quality and validation practices

Independently assess compliance practices and recommend corrective actions

Approve validated computer system related change requests

Monitor regulatory and inspection trends and advise the business on suitable action

Ability to create documents to an existing document standard.

Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)

Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.

Once trained, have the ability to work independently on CSV projects with minimal oversight.

Ability to perform in a highly matrixed organization structure