Validation Engineer InfoMedics
THIS JOB HAS EXPIRED Department:
QA ? Compliance
Validation Manager, QA-Compliance
General Position Summary:
The Validation Engineer?s role will be responsible for delivering and ensuring that all aspects of new and existing systems are validated and maintained in a validated state to SDLC requirements. You must have the analytical, organizational, communication and writing skills. You will need to be a self-starter who can work with limited direct supervision and drive to tight timelines with a sense of urgency.
Essential Job Functions:
Provide guidance and support to Development, SQC, Infrastructure and Solutions Design groups in creating applicable documents to maintain the system in Compliance with FDA regulations and guidance documents including GxPs, PDMA and 21 CFR Part 11 and industry accepted pharmaceutical practices.
Working with Software Development Team and other departments as needed on changes to code wherever is needed to meet business and compliance criteria.
Represent Validation and support QA activities in both internal audits and external audits.
A comprehensive review, creation, and execution of all documents related to computer system validation activities including but not limited to:
Validation Master Plans
Test Protocols and Use cases/li>
Validation Protocols including IQ, OQ and PQ?s
Validation Summary Reports
Standard Operating Procedures
Defining the validation and testing environment, validations steps and success criteria
Analyzing and resolving validation problems.
Develop and implement policies needed for an effective validation program ensuring compliance with FDA regulations and guidance documents including GxPs, PDMA and 21 CFR Part 11 and industry accepted pharmaceutical practices
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience:
BS (or equivalent)
2-5 years industry experience in software testing of internet based and mobile applications
Excellent working knowledge of MS Office particularly, Excel and Word
Excellent oral and written skills
Ability to work with and retain information of a confidential nature
Familiarity with FDA regulations including GxPs, Part 11 and PDMA FDA regulations would be a plus
Ability to read, analyze, and interpret common scientific and technical journals. Ability to draft a response to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to draft articles for publication that conform to prescribed style and format. Demonstrated ability to communicate technical issues to a wide range of audiences.
Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio and percent and to draw and interpret bar graphs. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to create and manage budgets. Ability to read various statistics.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and analyze several abstract and concrete variables.
There are no supervisory responsibilities.
About Physicians Interactive
Physicians Interactive was founded in 1996 and we have actively expanded our capabilities with clinicians ever since. With our acquisition of MedManage, Skyscape.com, and most recently InfoMedics, we have become the worldwide leader for trusted medical information delivered via mobile devices and the Internet. Physicians Interactive has been listed as one of the fastest growing companies and is a trusted partner for hundreds of clients over the years.
||Reading, MA |
THIS JOB HAS EXPIRED