Hi,
| Currently, I am recruiting candidates for one of my requirement as mentioned below. If you have a matching profile, please send me the updated resume along with contact details at the earliest. |
| Job Title | Software Developer |
| Project Location | Malvern PA |
| Duration | 12 months /Contract |
Skills Required and Job Description:
| MOI: - Telephonic + Skype MUST HAVE: C#/.NET in Pharma, or FDA Regulated Environment, OR EDMS Project experience Software Developer Consultant
Seeking a long term Software Developer Consultant for our client in the Wayne, PA area. Follows company software development lifecycle to design, code, configure, test, debug, and document system and application programs. Assists in preparing technical design specifications based on functional requirements and analysis documents. Reviews functional requirements, analysis and design documents and provides feedback. Collaborates with other development staff to achieve quality and consistency. Participates in architecture, design and code reviews. . Develops and maintains operational and system level documentation. Responsible for delivering and maintaining technology solutions to support Manufacturing Operations, Regulatory and Quality Systems. Primary function will be supporting the EDMS (Electronic Data Management System)
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
- 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: - Bachelor's 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
- 5+ years of experience in systems analysis and software development with in depth understanding of the system development life cycle
- 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
|
Thanks & Regards…..?
Vijay Saraswat
Technical Resource Specialist
RG Talent Inc
39120 Argonaut way
Suite # 157, Fremont CA 94538
(Phone: 510-443-0758 Ext - 124
7Fax No: 510-952-4633
8Email : vijay@rgtalent.com /Gmail:vijay.rgtalent@gmail.com
URL : www.rgtalent.com
yim /G talk --> vijay.rgtalent
In my absence please contact Rugen Nagar at the following address rugender@rgtalent.com
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