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Specialist, QA Engineering Analytical Development I Location: Newark/hybrid Duration: 6 months Description: The incumbent will be a part of the IT R&D Department and will perform and/or direct IT Infrastructure Qualification projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. This individual will ensure that GxP systems & underlying IT infrastructure meets the intended use and comply with applicable regulations, current industry practices, and Client policies and procedures. Qualification or Validation projects will primarily include IT Infrastructure but may include projects from other departments that support GxP operations. Essential Duties/Responsibilities Provide independent technical leadership and accountability for overall IT Infrastructure Qualification and CSV efforts Ensure quality and compliance is met in accordance with established procedures and standards of the Quality Systems by applying critical thinking on qualification and validation work Plan, generate, review and/or approve qualification or validation packages for IT Infrastructure or GxP systems in support of compliance activities Develop or assist with change controls, CAPAs, deviations, exceptions required as part of qualification/validation efforts Engage with IT stakeholders in supporting continuous improvements to the existing procedures and policies in relation to compliance and update those as necessary Perform gap analysis & necessary remediation efforts on current IT Infrastructure to ensure compliance with Part 11 and Annex 11 Collaborate/lead/participate in decision making and make recommendations regarding best options for qualification of computerized systems. Maintain close communication with stakeholders and team members to keep apprised of IT Infrastructure needs, & impact on GxP processes or operations Collaborate with Client approved vendor personnel in coordinating qualification or validation efforts to ensure successful system implementations Perform system assessments based on version upgrades/release updates on SaaS/Cloud based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments etc. Assist IT staff with business process deliverables such as process flows, data flows, user/operating procedures, work instructions and forms for GxP computerized systems Perform System Periodic Reviews ensuring that the systems are maintained in their validated state Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV Education Minimum Required: Bachelor's degree in Engineering, Science or related technological field Preferred: Bachelor degree in Pharmaceutical Science, Biomedical Engineering, or Management of Information Systems (MIS) or any related field. Experience Minimum Required: Minimum of seven (5-7) years or more in the pharmaceutical industry with GMP experience Understanding of Validation Life Cycle approach and practical working knowledge of computer system validation/computer software assurance requirements Knowledge of infrastructure qualification or validation of computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10 Demonstrate ability to effectively manage multiple projects/priorities and good understanding of SDLC phases and phase gates Experience with EDMS, VLMS, LMS and working knowledge of IT Infrastructure systems (AD, Backups, VMware, Monitoring at minimum) Demonstrate excellent written and oral communication skills. Effective time management and interpersonal skills. Must work effectively within teams with rapidly changing priorities. Demonstrates analytical problem-solving skills. Preferred: Relevant validation experience with Quality Systems, Manufacturing Systems, or Laboratory systems used within the pharmaceutical industry is a plus. Knowledge, Skills and Abilities Minimum Required: Risk Management Tools, MS Word, Excel, PowerPoint, Visio, Project and Outlook. As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.