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Project Description

A pharma company in the Amsterdam region is looking for a

The IT Validation Team Lead provides leadership for assigned projects and coordinates IT technical & validation project team resources and business resources in all aspects of IT project validation – planning, documentation development, test execution, and deviation identification and resolution for a pharmaceutical company global IT project portfolio.
Team Leadership
• Deliver Validation Specialist and Validation Test Execution training as needed.
• Act as mentor to IT Validation Specialists.
IT Projects
• Lead teams composed of IT and business professionals in computer system validation activities.
• Leadership role in analysis of current business processes and translation/documentation of these into Functional & System Requirements.
• Author Validation Plan, Design Specification, IQ, OQ & PQ Protocols, Traceability Matrix and Validation Summary Reports for assigned projects.
• Manage authoring of High Level and Detailed Risk Assessments.
• Manage authoring, dry running, & review & approval of IQ, OQ and PQ test scripts.
• Manage preparation of all validation deliverables for presentation to QA for approval.
• Write up and manage resolution and final disposition of all Deviations identified during test execution.
• Adept at coordinating competing priorities and projects. Broad experience in IT project validation and proven ability to lead validation activities of complex IT projects. This should include: understanding the business; determining business & system requirements; project planning; cost estimation, assigning validation project responsibilities; negotiating project deliverables
• Outstanding communication skills, both verbal and written. Ability to engage, interact, and negotiate effectively with project team members, both IT and business.
• Strong interpersonal, leadership and mentoring skills. Thorough understanding of risk management and mitigation approaches for complex organization and project issues.
• Results-oriented, pragmatic approach to problem solving. Ability to act as advocate for consensus on complex issues.
• Thorough understanding of how to work effectively within regulated pharmaceutical environment. Familiarity with U.S. FDA GxP, and U.S. FDA 21CFR Part 11, ISO 9001 systems validation. Experience in planning and execution of U.S. FDA-related Computer Systems Validation methodologies and project management implications.
• Thorough, applied understanding of SDLC and Project Methodologies.
• Experience in participating in large-scale business application deployment (e.g., SAP, Siebel, Cognos) and/or enterprise solutions for pharmaceutical, vaccines, or medical device manufacturing, research & development.( SAS applications)
• Occasional domestic and international travel may be required
• Understanding of client/server and web-based systems architecture concepts and network communications.
• Technical familiarity with Windows, Oracle, SQL, and Citrix technologies.
• Experience developing, implementing and supporting information systems in the pharmaceutical or biotechnology industries.
• Experience with systems integration and custom development projects
• Familiarity with network servers, PC clients, and telecommunications technologies
• Minimum requirement is a Bachelors degree in Computer Science or a related discipline.
• 5-8 years experience with information systems design, development, implementation and support, the last 3 of which involve computerized systems validation, preferably in the Pharmaceutical industry.
• A history of on-going professional training in topics such as project management, software engineering, validation, and client/server and web architectures.
• Proficient in use of all Microsoft Office solutions.

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