Hello There, If you have perfect match for the below requirement please forward updated resume of your available consultant along with the rates and contact details ASAP.
Please send resumes to [email protected] *Title Validation Engineer* *Location: Botham Seattle* *Duration: 6 Months* * * *General Position Summary: * The Validation Engineer’s role will be to work to ensure that all aspects of new and existing systems are validated and maintained in a validated state as required under 21 CFR Part 11 and MedManage Systems SDLC requirements. You must have the organizational, communication and writing skills to be able to analyze conflicting information. You will need to be a self-starter who can work autonomously and adhere to tight timelines with a sense of urgency. Understanding of regulatory compliance and industry accepted validation concepts is a must. *Essential Job Functions:* 1. Ensure all systems that are required to be 21 CFR Part 11 validated from the FDA perspective are fully and continually validated in accordance with all appropriate regulatory requirements and MMS SDLC and validation procedures 2. As directed by the Validation Manager, carry out the development of the Validation Plans that meet system requirements 3. Work with Software Quality Control on changes to code wherever is needed to meet program and compliance criteria 4. Supports Regulatory Compliance department during audits by clients as well as external audits of suppliers/vendors 5. A comprehensive review, creation, and execution of all documents related to computer system validation activities including but not limited to: a. User Requirements Specifications b. Functional Requirements Specifications c. Validation Plans d. Test Protocols and Use cases e. Traceability Matrices f. Validation Protocols including IQ, OQ and PQ’s g. Validation Summary Reports h. Standard Operating Procedures 6. Defining the validation and testing environment, validations steps and success criteria 7. Analyzing and resolving validation problems 8. Develop and implement policies needed for an effective validation program ensuring compliance with FDA regulations and guidance documents including cGMP’s (current Good Manufacturing Practices), PDMA , 21 CFR Part 11 and industry accepted pharmaceutical practices Regards, Nancy SACC Inc. Direct: 650-532-7465 Fax: 650-286-9020 Email: [email protected] www.saccinc.com -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. To post to this group, send email to [email protected]. To unsubscribe from this group, send email to [email protected]. For more options, visit this group at http://groups.google.com/group/sap-abap?hl=en.
