A pharma company in the Amsterdam region is looking for a
IT VALIDATION SPECIALIST (Contractor)
The IT Validation Specialist primarily assists in development and dry running of validation test scripts for IT projects in a pharmaceutical company global IT project portfolio.
• Participation as needed in analysis of current business processes and translation/documentation of these into Functional & System Requirements.
• Author IQ, OQ & PQ test scripts
• Dry running of IQ, OQ and PQ test scripts.
• Assist in preparation of test scripts for presentation to QA for approval.
REQUIRED SKILLS & KNOWLEDGE:
• Adept at coordinating competing priorities and projects. Experience in IT project validation including: understanding the business; determining business & system requirements; effort estimation
• 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.
• 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 execution of U.S. FDA-related Computer Systems Validation 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
DESIRED BACKGROUND & EXPERIENCE
• Understanding of client/server and web-based systems architecture concepts and network communications.
• Technical familiarity with Windows, Oracle, SQL, and Citrix technologies; network servers, PC clients, and telecommunications technologies
• Experience with systems integration and custom development projects
DESIRED EDUCATION & TRAINING
• Minimum requirement is a Bachelors degree in Computer Science or a related discipline.
• 2-5 years experience with information systems design, development, implementation and support, the last 1-2 of which involve computerized systems validation, preferably in the Pharmaceutical industry.
• Proficient in use of all Microsoft Office solutions.
3 freelancer bu iş için ortalamada 36€/saat teklif veriyor
I have good knowledge in both testing as well as regression testing of application, writing test scripts based on application functionality. Understanding business needs of customer with problem solving approach.