Job: Validation Specialist
Title Validation Specialist
Start Date 2013-01-21
End Date 2013-11-29
Location South San Francisco
Our client is looking for a Validation Specialist with deep experience in Software Quality Assurance and Computer System Validation (CSV). The candidate must have the ability to work in a team composed of validation professionals and on a cross functional project team. This candidate will be a creative, solution-minded thinker that has the ability to quickly adapt in a fast-paced, highly regulated environment.
* Experience performing analysis of current business processes to translate development documents into user requirements, and functional design specifications.
* Experience authoring Validation Plans, IQ, System Acceptance Test (SAT) Protocols, SAT Sctrips, Trace Metric, Risk Assessments and Validation Summary Reports for assigned projects.
* Experience in reviewing and approving of System Acceptance Test (SAT) Protocols and SAT Sctrips
* Experience in preparation of all validation deliverables for presentation to QA for approval.
* Experience authoring change control documentation for presentation to Change Review Board members.
* Experience in authoring protocol deviation documentation and in their resolution and final disposition.
* Outstanding communication skills, both verbal and written.
* Ability to engage, interact, and negotiate effectively with IT, QA, validation and business project team members.
* Experience with Trackwise applications and Crystal reports
* 5-8 years experience with information systems design, development, implementation and support, the last 3 of which involve computerized systems validation, preferably in the Life Sciences 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.
This position will be focused on Validation work for systems within the Regulatory Operations portfolio. These system help organize, track, and store Health Authority Submissions and Correspondence
Minimum requirement is a Bachelors degree in Computer Science or a related discipline.
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