Alimentiv Inc
London, ON, Canada
The Computer System Validation (CSV) Specialist is responsible for leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with computer system validation regulatory requirements e.g., 21 CFR Part 11, ICH guidelines) is always established and maintained. This
Job Source: Alimentiv IncGeneral Dynamics Land Systems - Canada Corporation
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The Computer System Validation (CSV) Specialist is responsible for leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with computer system validation regulatory requirements e.g., 21 CFR Part 11, ICH guidelines) is always established and maintained. This includes prioritizing, developing validation strategies, executing, maintaining, and coordinating CSV activities, evaluation of software applications against design specifications and user requirements and serving as the liaison between the appropriate IT, operational business units and external 3rd party partners/vendors (where applicable) on validation activities, in order to ensure project expectations are properly set and met. The CSV Specialist will oversee testing execution and may author/support software related documentation such as requirements, validation plan/protocol, trackability matrix, test scripts/cases, validation summary report and release documentation.
Software and System Validation Execute software and system validation according to established Quality Assurance procedures.·
Write software validation documents (plans, summaries, test cases, traceability matrixes, etc.) using standard operating procedures and good documentation practices.
Coordinate with other stakeholders during the validation planning and execution process to ensure that related activities (requirements gathering, testing) are planned and resourced appropriately.
Defect and Deviation Management Management of defects/deviations/incidents in validation projects, including:
Logging and organizing all defects/deviations/incidents identified during testing.
Running triage meetings with the required stakeholders to identify resolution – e.g., whether to fix and retest, or defer to a later release.
Ensuring the defect/deviation/incident log is updated with appropriate status prior to closure of the project for filing.
Coordinating and managing validation and qualification testing documentation review, approval signoff, execution, and post-execution review.
Validation Training Coordinate with IT, QA and applicable business units in the training of validation project team members on testing and validation policies, SOPs, practices and tools. This may include formal preparation of training materials, one-on-one training and classroom training.
Validation Lifecycle Management Provide guidance and assessment to ensure ongoing changes to validated systems are managed and documented in accordance with current corporate procedures and regulatory requirements.
Keep current with relevant industry and regulatory requirements, guidelines, and best practices.
Qualifications The successful candidate will possess either an Undergrad degree with 3-5 years of related experience and on the go training, or a College diploma with 5-6 years of related experience and continuous training.
Experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech or medical device environment. Experience in a matrixed environment and interactions with internal partners and vendors. College or university degree in computer sciences (e.g., IT, Information Security, Engineering, Software Programming, etc.) is required. Ability to communicate effectively both orally and in writing. Demonstrated understanding of quality system principles (training, documentation, change control, validation and audits). Excellent teamwork, leadership, interpersonal and relationship building skills. Good organization skills and attention to detail. Ability to prioritize work and consistently meet deadlines. Experience in working to Standard Operating Procedures is preferred. Working knowledge of relevant technology, tools, software and processes (SDLC), including automated enterprise testing tools is an asset.
$65,500 - $110,000 a year
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