Validation Specialist

Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionResponsibilities:Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processesFollow SOPs and industry best practicesConduct training on good documentation and good testing practicesFacilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer systemReview validation deliverables for projects which are contracted to third party suppliersMaintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issuesAssist in planning, implementing, and documenting user acceptance testingReview computerized systems validation documents such as:Design SpecificationCSV Risk AssessmentTest PlansTest Summary ReportsData Migration PlanPre/Post Executed Test ScriptsTraceability MatrixRelease to Production StatementsDirect and review testingProvide guidance on quality issues that affect the integrity of the data or the systemPrepare validation summary and test summary reportsObtain and respond to QA reviewParticipate in establishing standard quality and validation practicesIndependently assess compliance practices and recommend corrective actionsRequirements:Approve validated computer system related change requestsMonitor regulatory and inspection trends and advise the business on suitable actionAdvanced 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 yrs); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.Additional InformationAll your information will be kept confidential according to EEO guidelines.