Please send the resume with rate and contact details to

Roll: Senior Business Systems Analyst/Validation Lead
Location: South San Francisco - CA
Duration:6 Months

Only:US Citizens&GC-(Who can work on W2)

Job description,

Need from Pharma background with experience in GCP & GMP and all

Job Title:

Senior Business Systems Analyst/Validation Lead

Job Description:

·         This contractor will fill in a systems analyst/solution
lifecycle manager for projects within the Product Development
Informatics group supporting Global Product Development Clinical
Operations, Biometrics and Clinical Sciences business functions.
This role includes working on major cross-functional system

·         He/she will analyze the customer needs, assess risks,
perform impact analysis, define solutions, document requirements and
functional specifications, work with the development team, develop
validation and testing strategies and plans and validation/test
summary reports.

·         He/she will participate in the review of system change
requests and enhancements.

·         He/she will be asked to help in creating project plans with
regards to planning tasks and timelines related to his/her job

Job Duties:

·       Contribute to the development of new solutions / projects and
solution enhancements, provide subject matter expertise into detailed
solution design, and work with the development teams in the creation
of solutions to meet defined requirements

·       Act as Business Systems Analyst on major projects/programs and
may function in an analytical or design leadership role ensuring
successful completion and delivery

·       Author and/or review documentation throughout the project
life-cycle, and contribute to test planning, test execution and
testing documentation

·       Work directly with customer groups and proactively communicate
across global project work-streams and vertical teams, and take
responsibility for fostering and improving teamwork

·       Demonstrate and apply extensive understanding and application
of tools, principles, concepts, and techniques related to requirements
definition, data flow, usability and process analysis.

·       Contribute to management and support of solutions in their
operational status, coordinate activities related to changes for GxP
systems, provide content knowledge to the incident, problem and change
management processes

·       Perform 2nd and 3rd  level support and system administration
activities not managed by the Infrastructure or Development Centre
services and ensure system documentation is kept up-to-date in
compliance with the validation requirements of the solution


·        Strong user requirements, system analysis and technical
skills, as well as proven skills in documentation authoring

·        Must have experience developing risk-based system assessment,
impact analysis, validation plans

·        Experienced creating and/or reviewing installation
qualification, operational qualification and performance test

·        Ability to support prototyping activities that will validate
business requirements and solution definition

·        Experienced working in a project-driven environment. Project
experience on a regional/global scale is a plus

·        Excellent communication skills (written and verbal in
English, other languages are plus)

·        A self-starter who needs minor supervision

·        Ability to recognize and react to situations with a sense of
urgency and problem ownership/accountability, with a focus on customer


·         Bachelor’s degree in Computer Science, Informatics, Life
Sciences or a related discipline

·         A minimum of five years work experience as an IT business
analyst, systems analyst combined with software validation/quality
assurance experience with knowledge of pharmaceutical industry and

·         A good understanding of the principles of software
validation in regulated industries is a plus, including 21 CFR Part
11, PDA 18, related FDA guidelines and regulations, as well as ICH GCP

·         Knowledge of clinical trial management systems (CTMS),
clinical trial portals (CTP), Electronic Data Capture (EDC) systems,
document management systems such as Livelink, Microsoft Sharepoint,
SAS, R-Software, Secure Data Exchange a plus


GALLOP Resources, Inc
1220 N Market Street, Suite 806,
Wilmington, Delaware, 19801

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