Hi,
Hope you are doing well.

IFinite Solutions is ITSM and Technology Solution provider based out of
Parsippany, NJ. Seeking for a* Sr Business System Analyst* at *Malvern, PA *for
*12+ months contract *position.If you have any consultants with this
position kindly reply with your updated profile along with their contact
details.

*Responsibilities: *
•Manage the maintenance and implementation of system upgrades and
enhancements to the MasterControl EDMS system and provide end user support.
•Troubleshoot and assist in resolution of operational issues for software
applications
•Create/Modify SQL objects for scripting, reporting and troubleshooting.
•Gather requirements, create design specifications, and develop application
enhancements, data interfaces and reports.
•Identify and lead continuous improvement projects partnering with business
stakeholders to define project scope, business requirements, project
approach, budget, and schedule.
•Participate in the design and development of test plans for executing
unit, integration, system and validation testing ensuring FDA and other
regulatory compliance
•Develop and execute software validation protocols for version upgrades
•Provide guidance in the areas of industry best practices as well as
systems and solutions to improve effectiveness and efficiency.
•Ensures all applicable electronic systems, including hardware, software,
networks, etc. meet all FDA other regulatory requirements.

*Required Skills:*
•Bachelors Degree (B.A.) from a four-year college or university ;
preferably with an area of concentration in Computer Science or Engineering
with a minimum of 5 years related experience and/or training
•Need 5+ years of experience in systems analysis and software development
with in depth understanding of the system development life cycle
•Need 5+ years design and coding with software development tools such as :
C#, Java, JavaScript, .Net, SQL Server, HTMA/DHTM/XML
•Experience with electronic document management systems in FDA regulated
medical device or pharmaceutical company, experience, MasterControl
preferred.
•Hands on development experience with SQL Server 2008, stored procedures,
triggers,
•Knowledge of processes in one or more areas of manufacturing, quality
regulatory
•Knowledge of and experience with cGXP Software Validation, applicable FDA
regulations and ICH guidelines.
•Working knowledge of ERP applications highly desirable
•Strong skills in the areas of team facilitation, process mapping,
solutions requirements gathering and problem solving.
•Strong communication skills and ability to write reports and procedure
manuals

*For quick response, kindly forward your consultant`s profiles to
[email protected]*

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