Validation Analyst 1
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About The Position
Responsible for overall validation project ownership of limited risk project(s) under heavy supervision. Responsible for generation and execution of validation protocols, assistance in audits, and determination of validation needs. This job has no supervisory responsibilities. Performs validation activities to assure compliance to government and customer requirements. Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer / product / system project launch and maintains existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals, as needed. Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required. Prepares change control and validation history report for audits. Attends conference calls and meetings. Effectively communicates project goals and progress to Validation Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project. Primary contact for quality validation activities and managing expectations. Reviews and interprets standards, procedures and specifications for dissemination relative to validation protocols. Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements. Required to complete and pass a 'Documentation Boot Camp' course within 6 months. This position may require overtime and/or weekend work. Attendance to work is an essential function of this position. Performs other duties as assigned.
