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Software Validation Engineer

Location:Central Region, Singapore
Job Type:Permanent
Posted:4th Jan 2010
Closing Date:1st Feb 2010
Posted By:Direct Advisory Group
Details:
Software Validation Engineer

Our client is a Nasdaq listed medical technology company.

This position will be based in Singapore.

Requirements:-

-BS degree in Software Engineering, Industrial Engineering, or other Engineering discipline or equivalent experience
-Minimum of 3 years related experience in software validation
-Experience in validation in the medical device industry or other FDA-related/cGMP environment.
-Working experience with FDA software guidelines.
-Proficient with C++, Java and SQL.
-Experience in writing validation test documents.
WEB application testing
-Proficient at MS-Word, Excel, Acrobat, Access
-Familiarity with Enterprise Software Applications.
-Strong communication (written/verbal) skills.
-Ability to communicate at multiple levels of an organization
-Ability to organize and judge priorities
-Ability to generate and maintain accurate records


Responsibilities:-

-Create, develop and manage Business / Quality System Software validation projects.
-Modify the configuration of Business / Quality System Software as needed.
-Analyze requirements and design for validation activities.
-Develop Validation Scripts, Protocols and Reports, and provide the training related to the implementation.
-Manage policies, procedures and processes associated with validation services area and suggest changes and improvements.
-Manage implementation and validation teams associated with Business / Quality Software.
-Develop training manuals for Business / Quality Software and assist in creating Procedures.
-Conduct periodic assessments of all existing validated systems for compliance to regulations, standards and policies.
-Develop and maintain strong networking relationships throughout Insulet and actively participate in initiatives to establish policies, global processes or guidelines.
 
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