Innovations technological

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 susheel@ifinitesolutions.com; for more details can reach Susheel at 973-794-1187.