Job Description
Documentation Clerk assigned to the documentation repository area for the site, and its integrated units, such as SOP, Training, and Change Request systems. Provides measurement and performs monitoring for compliance through metrics for every unit and/or system as required. General Duties: Assign protocol numbers for Change Requests (CR) and qualification protocols such as IQ, OQ, PQ, IOQ, AIQ and AOQ etc. Follow up the closing of the CR and maintain KPIs associated. Receives and revises the CRs documents for completion to be included in the repository. Works with the generation, evaluation, revision and completions until implementation of Packaging Components Specifications (PCS). Updates PCS Master List based on specification or component changes, package BOM revision (Paper BOM) Works with the addition and/or update of training curricula/profiles in the training systems. Manages site procedures, forms, guidelines, production batch records and flowcharts. Executes documents workflows...
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