*Dear Partner , Hope you are doing good. * *Title: Sr. Validation Specialist – Maximo*
*Location: New Brunswick, NJ* *Duration: 6 Months * *Must have pharma industry exp. Experience with Maximo is required.* *Must have knowledge of Software Validation Life Cycle and the document deliverables associated with the life cycle. Experience is required. *( *Please only submit resumes with Maximo experience)* * • 6+ years experience • Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes • Follow SOPs and industry best practices • Conduct training on good documentation and good testing practices • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system • Review validation deliverables for projects which are contracted to third party suppliers • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues • Assist in planning, implementing, and documenting user acceptance testing • Review computerized systems validation documents such as: o Requirements Specification o Design Specification o CSV Risk Assessment o Test Plans o Test Summary Reports o Data Migration Plan o Pre/Post Executed Test Scripts o Traceability Matrix o Release to Production Statements • Direct and review testing • Provide guidance on quality issues that affect the integrity of the data or the system • Prepare validation summary and test summary reports • Obtain and respond to QA review • Participate in establishing standard quality and validation practices • Independently assess compliance practices and recommend corrective actions • Approve validated computer system related change requests • Monitor regulatory and inspection trends and advise the business on suitable action* *-- -- --The referral of your friends and colleagues are appreciated. Please ignore if you receive this message in Error and sorry for the inconvenience. With Best Regards, Victor Spencer. Direct: 732-658-9251 Fax: 732-348-9590 |e mail: [email protected] | Yahoo IM: [email protected]| GTalk : victor. astoline | Website: www.astoline.com| 517 Route one South, Ste#3333, Iselin, NJ - 08830 * --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "KNOW.IT" 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/KNOW_IT_AZ?hl=en -~----------~----~----~----~------~----~------~--~---
