Computer System Validation Specialist

Descripción del Empleo:
The Candidate will be involved in all aspects of computer systems validation and qualification activities as part of an overall SDLC approach. The candidate will provide validation and compliance consulting and project support on various technology development and implementation projects, including planning, solution design, testing, and support. Responsibilities:
•Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, System, Validation Reports, SOP's, Change Control Documentation, and Risk Assessment reports.
•Managing and coordinating all aspects of the CSV as they pertain to SDLC, including project planning, developing validation strategies, document development, and document reviews.
Requisitos:
Minimum Qualifications: A Bachelor’s degree in Engineering or Life Sciences with five or more years of experience in pharmaceutical, biotechnology, medical devices or other regulated industry.

Experience with any of the following: Computer Systems Validation / QA within FDA (GxP) regulated environments; automated testing tools, validating and qualifying various IT systems used in clinical environments; developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases; validating a serialization or track & trace project is highly advantageous; understanding of packaging processes, warehouse and distribution streams.