A new Job, ID: 158204 <http://www.ejobsville.com/display-job/158204> was added at eJobsVille.com - For the Best Tech Jobs in Town<http://www.ejobsville.com>
Title: validation engineer medical devices posted on 2014-04-28 11:26:03 Job Description:*Responsibilities:* 1. Responsible for managing and executing the validation of non-product software applications (including, but not limited to ERP System, PDM system, CAPA Management system, Reports, Spreadsheets, MES system). 2. Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR Part 11), guidelines and internal procedures related to validation of computer systems, E&AS and associated infrastructure are followed and applied during all stages of the defined software development life cycle (SDLC) and project phase activities. 3. Creates validation and qualification deliverables, such as change impact assessment, user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc. for new software, enhancements, maintenance releases, and periodic reviews. 4. Analyzes the validation impact of changes and helps in formulating the validation plan for changes to existing or new computer systems. 5. Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with Quality, obtaining signature approvals, executing qualification protocol or validation project plan, managing change control (change requests). 6. Supports risk assessment and system lifecycle processes such as change control and document management. Job Requirements: *Skill Matrix:* *Required skills**No. of years of experience**Last used year* Validation of non-product software applications Medical devices industry exp FDA regulations 21 CFR Part 11, Part 820 GAMP5 IQ,OQ,PQ, Validation Master Plan Risk Assessment User and Functional Requirements specification *Click here to view full job description and apply <http://www.ejobsville.com/display-job/158204> (Registration not mandatory to apply for this job)* ------------------------------ Best regards, eJobsVille.com - For The Best Tech Jobs In Town -- You received this message because you are subscribed to the Google Groups "Open Source Erp & Crm" group. To unsubscribe from this group and stop receiving emails from it, send an email to open-source-erp-crm+unsubscr...@googlegroups.com. To post to this group, send email to open-source-erp-crm@googlegroups.com. Visit this group at http://groups.google.com/group/open-source-erp-crm. For more options, visit https://groups.google.com/d/optout.
