![]() Experience with Documentum Electronic Document Management System (EDMS) is required.Working knowledge of GMPs and related Quality System processes is required.Minimum of 3 years of experience working in Quality, preferably in the pharmaceutical industry or other regulated environment.Bachelor of Science or equivalent industry experience working in the Quality area.Distributes timely notifications to NAM locations on the publication of Global Quality Management documents.Generates and distributes monthly metrics reporting on the status of 36-month document reviews of Policies and SOPs to facilitate compliant processing.Performs weekly follow up of Change Notices to ensure processing towards completion.Training includes off-site travel in support of all NAM locations. Performs training of employees on Documentum software functionality.Ensures on-time review and approval processing of cGMP documents.Coordinates and issues Document Change Notices (DCNs) associated with GO NAM sites, Packaging & Development, Regulatory Affairs, Contract Manufacturing, Innovation & Development and Sales & Marketing.Verifies compliance of all cGMP documents and data processed including, but not limited to, the document types of electronic Change Notices, paper-based Document Change Notices, Policies, SOPs, Specifications, Methods of Analysis and Protocols.Interfaces with the departments of Innovation & Development, Regulatory Affairs, Contract Manufacturing, Packaging Development and Sales & Marketing to ensure accurate approval of documentation and in support of new Product Launches. Assists department Material Part Number assignment for Finished Products to ensure accurate, consistent, compliant and efficient maintenance of records.Responsible for the processing of electronic Change Notices using the Documentum Electronic Document Management System (EDMS) and paper-based Document Change Notices (DCNs) and preparing metrics that report on the compliance of cGMP documentation.The Quality Assurance Specialist functions as a regional role supporting all sites within North America ensuring all QA data and reports subject to FDA inspection are in alignment with SOP and cGMP requirements.
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