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Senior IT Software Validation Analyst

Trumbull, CT
Our Client is looking for Senior IT Software Validation Analyst for a direct Perm position who will be responsible for the validation of global systems, monitors changes in regulations and makes changes to corporate strategy to meet the needs of the regulations.


Job Summary:
Ensures the correct processes are followed to validate our current portfolio of systems and ensure they are maintained in a validated state. Work closely with RA/QA Validation Director and key IT application stakeholders for timely and accurate validation.


Essential Functions & Accountabilities:
  • Writes and reviews computer system validation documentation including computer systems validation (CSV) plans, risk assessments, traceability matrix and summary reports
  • Provides input to development of corporate standards, policies, and standard operating procedures (SOPs) for Information Systems
  • Leads members of the project management office (PMO) and IT PMO in areas of QA Compliance and CSV.
  • Works closely with other compliance analysts and internal audit on harmonizing control requirements and frameworks
  • Trains and mentors project team personnel (developers, business systems analysts) at company level in computer system lifecycle methodology
  • Provides guidance with functional/ end user requirements, compliance and system specifications, and ensures that proper documentation is maintained
  • Provides guidance in planning, implementing, and documenting user acceptance testing
  • Analyzes formal test results in order to identify weaknesses/failures in control performance and documentation -
  • Review’s requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements
  • Identifies critical issues with ease by utilizing both IT knowledge and Quality Management process knowledge resulting in effective solutions
  • Ensures compliance with internal and external computer system lifecycle policies and regulations
  • Incorporates periodic reviews and remediation activities on validated systems into the Validation program with reportable outcomes
  • Oversees small projects and/or tasks and phases of larger projects. Responsible for coordinating activities of teams, schedules and resources for assigned tasks or projects
  • Maintains current system inventory listing
  • Interacts with auditors (FDA, SOX) to provide necessary documentation
  • Develops relationships with the user community that fosters trust and the ability to work in partnership.
  • Communicates effectively with users to identify needs and evaluate alternative business solutions with project/Quality Management
  • Ensures issues are identified, tracked, reported on and resolved in a timely manner.
  • Works with the users to identify required changes.
  • Research, communicate and demonstrate “best practice” opportunities for the local/regional organization, allowing key decision makers and local/regional managers the opportunity to leverage “best practice” as a strategic and competitive advantage for the organization.

Qualifications
Knowledge, Skills and Abilities:
 
  • Experience in Software Quality Assurance and Computer System Validation and Requirements Analysis.
  • Familiar with Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies and frameworks.
  • Experience and knowledge of Agile PLM or equivalent system
  • Knowledge of Regulatory Procedures FDA 21 CFR Part 11, Part 820, SOX and 1503485 with good understanding of GxP related processes including risk-based approach and validation
  • Adherence to IS policies and procedures to ensure quality of service and compliance with regulatory requirements
  • Ability to engage, interact, and negotiate effectively with IT, QA, validation and business project team members.
  • Prior exposure to manufacturing, supply chain and logistics operations would be beneficial.
  • Good analytical and problem-solving skills
  • Ability to adapt to a fast and dynamic environment.
  • Ability to effectively translate between functional and technical teams
  • Ability to follow, produce and maintain procedures and supporting documentation
  • Excellent written, oral, and interpersonal communication skills
  • Excellent time management
  • Highly self-motivated, self-directed, and attentive to detail
  • High level of experience in organizing and chairing meetings
  • Extensive experience working in a team-oriented, collaborative environment
  • Ability to communicate effectively with management
  • Adapts readily to changes in workload, staffing and scheduling


Experience:
  • 5 to 10 years' experience in assigned function's business process and supporting systems
  • Commensurate Technical experience to perform the job duties
  • Must be proficient with Microsoft Office
  • Experience with automated systems for following activities/functions is helpful:
  • Enterprise Resource Planning (D365)
  • Document management (MasterControlint)
  • Change/Incident Management (ServiceNow)
  • Project/Task Management (SmartSheets)


Education:
  • Bachelor of Science Degree / Diploma in relevant field required; or an equivalent combination of education and experience is required



 

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