PROJECT MANAGER, IT – Princeton, NJ
Coordinate and manage a number of concurrent project
activities involving multiple team-members, third-party vendors,
and client departments implemented across various regions. Develop
project schedules, work breakdown structures and Gantt charts
using project management tools such as MS Project and e-Project.
Train and educate IT and business co-workers on the importance
of Computer Systems Validation (CSV, Systems Development Life
Cycle (“SDLC”) in a pharmaceutical company) and
details of the deliverables to be developed during a CSV project.
Analyze, audit and validate a wide variety of computer systems,
such as Batch Production Record Printing Solution, ERP System,
Pharmacovigilance and Drug Safety System, Chromatography Data
System, Citrix MetaFrame Server 4.0, and Document Management/Archival
Solution, currently used in the automation of certain business
practices for various departments within the organization, for
any gaps and develop the necessary CSV documentation. Develop
policies, guidelines and SOPs/Templates governing the IS and
CSV activities after interacting with the required SMEs and
departmental heads. Develop and/or review and approve the validation
documentation for computer/laboratory systems being used in
a FDA-regulated environment to ensure compliance with internal
policies, system requirements, and industry regulations. Develop
other project deliverables such as Feasibility Study, Traceability
Matrix, Risk Assessment, System Retirement Plan, Summary Report,
and System Release Certificate.
Qualified applicants must have the following:
 |
Master’s degree
or foreign equivalent in Computer Science, Computer
Engineering, Information Systems or related; |
|
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Two (2) years’
experience in a related occupation such as Systems Lead
– Information Systems, Programmer/Validation Analyst,
Validation/Systems Analyst – IT, Intern –
Information Technology or related; |
|
Two (2) years of (a)
progressive experience doing Computer Systems Validation
(“CSV”) in a pharmaceutical environment,
managing CSV/IT projects from inception to completion
and developing and/or modifying CSV/IT strategies; (b)
experience with SAP R/3, Document Management and Archival
Solutions (such as Kofax Ascent Capture, Microsoft SharePoint
and Documentum), CRM tools (such as Siebel and SAP CRM),
Qualifying Citrix Servers and LIMS; and (c) management
experience including in-depth knowledge of project management
methodologies and project management skills; |
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Experience can be concurrent;
and |
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Employer will accept
any suitable combination of education, training or experience
that is equivalent to the actual minimum requirements
of the position and shows demonstrable ability in the
skill sets required for the position. |
Interested applicants should submit their resume with Ref
#: 48774/16 to Desiree Timmerman at desiree.timmerman@ranbaxy.com.
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