Sr. Validation Lead

Company: OnShore Technology Group
Location: Chicago
Posted on: January 28, 2023

Job Description:

For over 15 years, we have worked as a trusted partner with our clients as well as many global system integrators and technology companies to help deliver turnkey validated systems and ensure sustained compliance.OnShore's leading innovation is ValidationMaster---, the first Enterprise Validation Management System (EVMS) of its kind to include a validation Kanban board and seamless integration with our unique ValidationMaster Quality and Risk Management portal.The Sr. Validation Lead is primarily responsible for oversight of V&V activities for designated computerized system implementation projects. This position requires a senior-level individual with strong experience in supporting computer system validation (CSV) efforts for applications used in GMP, GLP and/or GCP processes ensuring adherence to internal procedures, industry practices such as ISPE GAMP 5, and applicable regulations such as FDA 21 CFR Part 11, EudraLex Annex 11, SOX and cGMPs.ROLES & RESPONSIBILITIES

• Ability to lead and coordinate multiple CSV projects
• Develop / review validation test protocols as required using automated technology tools
• Coordinate / communicate with other departments, SMEs
• Ensure that all validation deliverables are prepared in accordance with internal guidelines, policies and procedures
• Create, track and manage all validation project plans
• Provide regulatory guidance on principles of CSV to the expanded team EDUCATION & CERTIFICATION
  • B.S. or equivalent in computer science, engineering, life sciences, or related field
  • Minimum 10 years of experience in software quality assurance in the life sciences industry in a leadership role
  • ASQ CSQE Certification or equivalent preferred
  • Practical working knowledge of software development and implementation methodologies
  • Experience with the validation of Enterprise Resource Planning (ERP) systems is preferred.
  • Strong oral and written communication skills in English.
  • Excellent interpersonal skills.
  • Advanced skills at team management, organization, and communication of priorities and listening
  • Practical experience in conducting and supporting CSV audits and inspections.
  • Advanced proficiency in the use of Microsoft Office desktop applications REGULATORY KNOWLEDGE REQUIREMENTS
    • U.S. FDA Validation Guidance Document
    • 21 CFR Part 11 Electronic Records; Electronic Signature Final Rule
    • U.S. FDA Data Integrity Guidance
    • NIST Cybersecurity Framework
    • 21 CFR Part 210/211 cGMP
    • EUDRALEX Annex 11 Rules Governing Medicinal Products in the EU, Volume 4

Keywords: OnShore Technology Group, Chicago , Sr. Validation Lead, Other , Chicago, Illinois