Technical Project Manager

3 settimane fa

Lazio, Italia Confidenziale A tempo pieno

*Job Description In this position, you will be directly involved in the technical project management and execution of computer system validation engagements in conjunction with the Global Service and Support teams. Efficiency, accuracy, a keen willingness to learn, and the ability to work effectively with multiple stakeholders in a multi-cultural and geographically distributed environment are essential to success in this job.*Responsibilities:
**Interact with external stakeholders at all levels including laboratory scientists, laboratory technicians, laboratory directors, IT, QA and regulatory staff and/or consultants. Master the documentation and execution process behind Computer System Validation. Practice continuous PPI thinking. Identify opportunities in laboratory workflows and data integrity where the company can offer value-added services to speed production deployment of platforms, increase customer retention and prohibit competitive entry. Develop and pilot value-added services and support product commercialization process forthese services (PCP). Work effectively in an FDA regulated and/or ISO compliant environment. Identify areas for process improvement in the development, training and delivery of these services. Additional and incidental work related to the primary duties may be required for company business needs from time to time. Travel (~30-50%) will be required for customer onsite visits. (global)*Education Bachelors or Master's Degree in a Scientific or Computer Sciences discipline*Experience* In-depth knowledge and experience with performing and/or developing Computer System Validations Keen understanding of quality systems and operating in a GMP environment. Excellent communication (verbal and written), negotiation, presentation, and interpersonal skills Knowledge, Skills, Abilities** Documentation management/generation in a Content Management System a plus Working knowledge of statistical methods. Working knowledge of global regulated markets (FDA, CLIA, CAP, CFDA, etc).* Experience with html and /or xml a plus

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