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Validation - Compliance Specialist

Company: Katalyst Healthcares & Life Sciences
Location: New Brunswick
Posted on: June 25, 2022

Job Description:

Job Description Responsibilities:Evaluates and administers consultation on computer validation issues related to Quality related computer systems; works closely with Information Technology and Quality Operations on these related issues.Ensures enterprise level metrics and tracking for Corporate Computer related CAPAs are maintained and reported appropriately.Develops and implements policies and procedures related to Quality related system compliance activities related to Risk assessments, validation and the overall maintenance of system state of control.Ensures compliance with all Company policies and procedures, including safety rules and regulations.Partners with IT Validation to ensure risk assessments, incident management and oversight are aligned to corporate and data protection standards.Performs related duties as assigned.Requirement:Bachelor's degree in a related field from an accredited college or university, with a minimum of 5 years of related experience21CFR11/ EU GMP Annex 11 and GAMP 5 standardsData Integrity GuidanceGood Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirementsProject management practices and techniquesSoftware development life cycleComputer hardware and software applications including Quality related computer systems, MS Office and MS ProjectPrinciples and practices of computer compliance, validation and qualificationKnowledge of automated testing practices and tools a plusExternal and internal inspectionsStakeholder management in a cross-functional organizationReviewing user, functional and design specifications.Reviewing and executing protocols and test scriptsSampling, testing and measuring techniques.Analyzing and troubleshooting problems, identifying solutions, recommending, and implementing methods, procedures and/or techniques for resolution.Selecting, training, supervising and evaluating departmental personnelManaging multiple projects, duties and tasks,Communicating clearly and concisely, both orally and in writing.Establishing and maintaining effective working relationships with those contacted in the course of work.: 21-01004 : New Brunswick, NJ:

Keywords: Katalyst Healthcares & Life Sciences, New Brunswick , Validation - Compliance Specialist, Other , New Brunswick, New Jersey

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