*Hi,* * *
*IFinite Solutions is ITSM and Technology Solution provider based out of Parsippany, NJ. Seeking **for a **Software Developer (EDMS)* at *Malvern PA* * *for *12+ months* contract * * *Note: *Must have FDA regulated medical device or pharmaceutical experience. * * *Requirements Skills:* · Must have 5+ years of experience in systems analysis and software development with in depth understanding of the system development life cycle · Required 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 · 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 . *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. Do send resumes to sush...@ifinitesolutions.com; for more details can reach Susheel at 973-794-1187. -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to us_itgroups+unsubscr...@googlegroups.com. To post to this group, send email to us_itgroups@googlegroups.com. Visit this group at http://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/groups/opt_out.
