Dear Business Partner,
We have an urgent requirement for Senior Validation Specialist – Business Analyst in NJ, please check the job description and forward your consultants resume with contact no and hourly rate. Here is the job description: Title: Senior Validation Specialist – Business Analyst Duration: 6 months Location: Princeton, NJ Hiring Manager's Notes: Requires the ability to: • Pharmaceutical Background is required • Quickly come up to speed on BMS CSV methodology and procedures • Have impeccable communication skills - both oral and written • Be flexible in their work schedule based on project needs • Effectively represent QA at project meetings • Lead validation efforts independently • Develop validation plans with minimal guidance and produce quality documents under tight deadlines • Facilitate and document risk assessments between business, IT and compliance organizations • Perform quality reviews of SDLC deliverables • Summarize test results based on evidence supplied • Document Installation Qualifications This is not a tester or test lead position. Job Description: • 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 -- Regards, Gabriel Agile Enterprise Solutions, Inc || "Ensuring Client's Success"|| Ph: (630)-242-8896 x 302 Fax: (847)-890-6357 www.agilees.com|| Email: [email protected] --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "SAP BASIS" 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-BASIS -~----------~----~----~----~------~----~------~--~---
