*** NEW REQUIREMENT *** SENIOR COMPUTER VALIDATION SPECIALIST REQUIREMENT #13-00656 RECRUITER: KAREN GULUTZ JOB LOCATION: NEW BRUNSWICK, NJ JULY 11, 2013 Responsibilities: • 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 that 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 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 Required Skills: • 6+ years’ experience • Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. • Ability to create documents to an existing document standard • Working knowledge of Documentum • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. • Able to develop all documentation required for a 21/11 validated project, including validation plans and summaries • Experience in producing software documentation and business requirement documentation (minimum 3 years); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance. This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Karen: karen@alphaconsulting
Posted on: Thu, 11 Jul 2013 18:09:34 +0000
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