Computer Systems Validation Analyst - Jobs in Halifax, NS

Job Description

NTT Data is seeking a Computer System Validation Analyst experienced in Life Sciences GxP software validation to operate as a key member of application upgrade and installation projects representing the CSV department in all project meetings and discussions.Author, and manage the review and approval of key CSV deliverables including the Validation Plan, URS, FRS, DS, IQ/OQ/PQ, Traceability Matrix, Test Plans, and Reports, Validation Report in client or NTT eDMS or VLMS.Work with client QA department to coordinate and ensure on-time delivery of all CSV deliverables.Participate in all roll-out activities for the project and maintain relevant documentationWork with stakeholders and business representatives to document requirements, qualifications and user acceptance test scripts that adequately ensure business requirements are met for a given systemEnsure close collaboration with appropriate system owners and key stakeholders in the businessEnsure that GxP applications maintain their validated state during the system lifecycleProvide system audit support and ensure inspection readiness of applicationsWork with QA, Computer Systems Validation Committee, and IT to document CAPAs, audit observations and other quality itemsReview of application vendors qualification and/or validation documentation, as applicableWork with vendors for change control management, incident management and issue resolutionProactively identify and collate information required to assess compliance with processes and prioritize business process improvement needs.Review, assess and update procedural documents for overall compliance with current processes, as requiredProactively collaborate with initiative leads and senior management to develop, optimize and improve CSV processes, training, and communicationsPerform special projects, assignments, and administrative tasks per business needsProvide guidance and review or create varied support materials, presentations, and/or tools to support departments remit and strategies.Mentor, coach, and support team membersEducation and Experience4+ years of experience working in electronic based Computer System Validation in a GxP environmentSignificant experience in authoring, reviewing and execution of validation and qualification documents, including test scripts.Knowledge of practices and procedures of the full software development life cycleStrong attention to detailHands on experience with eDMS tools like Documentum or Master Control, as well as testing tools like Jira, ALM, etc.Bachelors degree or equivalent and relevant formal academic / vocational qualification or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).GAMP, GxP and VLMS/eDMS application training (desirable)Desirable Knowledge, Skills, and AbilitiesStrong knowledge of software development lifecycle, GAMP and CSV processesWorking knowledge of GxP, FDA, EU and other relevant regulatory requirements for Pharma, Biotech, and med devices.Ability to develop/update validation project plans and computerized system lifecycle program documents to deliver large CSV projectsSignificant experience in authoring, reviewing and oversight of the execution of CSV documents, including Validation Plan, functional and regulatory risk assessments, User/Functional/System/Data Migration Requirements, IQ/OQ/PQ protocols, test plans, test scripts and test reports, traceability matrices as well as Validation Reports.Hands on experience with common tools and processes within the digital validation arena (Jira, ALM, Master Control, Documentum, First Doc, TX3, Kneat, ValGenesis, etc.)Understanding and experience with automated testing, including tools like Tosca and Leap Work (desirable)Good knowledge and experience with maintaining the validated state, including Change Management, CAPA, audits, etc.Strong problem-solving, verbal, written and presentation skillsComputer literate with the ability to work within multiple databasesProficient in Microsoft Office products (including Outlook, Word, and Excel)Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervisionAbility to maintain a positive and professional demeanorAbility to work effectively within a team to attain a shared goalProject management experienceThe Company is an equal opportunity employer and makes employment decisions on the basis of merit and business needs. The Company will consider all qualified applicants for employment without regard to race, color, religious creed, citizenship, national origin, ancestry, age, sex, sexual orientation, genetic information, physical or mental disability, veteran or marital status, or any other class protected by law. To comply with applicable laws ensuring equal employment opportunities to qualified individuals with a disability, the Company will make reasonable accommodations for the known physical or mental limitations of an otherwise qualified individual with a disability who is an applicant or an employee unless undue hardship to the Company would result.Quick Apply

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