Administer the document management system (DMS) for SOPs, batch records, protocols, reports, and other GMP-controlled documentation.
Process document initiation, revision, review, approval, issuance, and distribution workflows.
Ensure document version control, archiving, retention, and retrieval activities comply with GMP and Good Documentation Practice (GDocP) requirements.
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Maintaining document archives – Both electronic & Hard Copy while ensuring all records-management activities adhere to good practices, policies and legal requirements
Fulfilling document retrieval requests
Conducting periodic audits to ensure adherence to document control process and procedure
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Support the maintenance of documents, including document tracking, library/document placement, binding and copying, to ensure availability for departmental office activities.
Support the coordination of document delivery, submission and handover to/from customers and subcontractors.
Support the preparation, operation and maintenance of the document control database.
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Assign/Grant permissions to users in OpenText, manage security levels, and act as a Super User for the OpenText application for the assigned region.
Ensure full alignment of the overall document management process with the Global procedures and job-aids.
Identify opportunities for process improvements in the Document Management System and work with Global Administrator(s) and Regional Power Users to implement the same.
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