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The opportunity
This position provides Quality Documentation support for the cross-functional departments. This position has the responsibility to support Document Control functions in a pharmaceutical environment.  This person will assist in ensuring compliance with regulatory requirements and will interact with all areas within the company to ensure that change coordination and publishing of documents are completed in a timely manner with a high degree of accuracy.  
How you’ll spend your day
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. 

Responsible for independently performing day-to-day tasks that occur in a Document Control Function (typing, filing, research, etc.).
Responsible for assisting in coordination of the review and revision of controlled documents (master batch records, procedures, specifications, test methods and forms) to ensure consistency in format and presentation of content for all documents.
Responsible for helping to ensure adequate and compliant document change control practices.
Responsible for assisting with the organization and maintenance of files for submitted documents, all master documents and document history as needed.
Responsible for issuing documents, and GxP records to appropriate personnel, in a timely manner.
Responsible for effectively interacting with other functional groups (e.g., Production, external regulatory affairs, etc.)
Responsible for assisting in the coordination of activities related to the implementation and maintenance of an EDMS (electronic document management system).
Responsible for assisting in writing and/or revising departmental Standard Operating Procedures as needed.
Responsible for effectively addressing CAPA and deviation resolutions as needed.
Responsible for generating reports from EDMS and other software applications.
Responsible for supporting regulatory agency audits with ability to field and respond to audit requests (backroom lead).
Responsible for representing Document Control on project/product teams as assigned.
Responsible for training and providing guidance to lower level employees as needed.
Responsible for completing training requirements and maintaining compliance with all assignments.   
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions. 
Responsible for performing additional related duties as assigned.