QUMAS Engineer

Job Description:

• 8 to 10 years of experience in QUMAS experience in Quality and Compliance Management Solutions for the Life Sciences and regulatory compliance.
• Hands-on with Document, quality and incident management software to ensures compliance with global regulations.
• Hands-on with the QUMAS Compliance Platform that provides access to all compliance initiatives across controlled content and processes through one user interface, reducing the number of point solutions needed to address regulatory mandates.
• Experienced with using the Platform to combine document migration, regulatory submissions, training and collaboration capabilities in one central location, simplifying task management and regulatory reporting.
• Hands-on with QUMAS solutions for Document & Quality Management to provide Electronic Document Management (SOPs, QA documents), Process Management (CAPA, Deviation, Change Control, Audit), and GMP Compliance Management.
• Awareness on QUMAS Regulatory Affairs solutions to provide Submission Management including eCTD authoring templates, scanning and automated importing of paper documents and the migration of documents from legacy systems, as well as collaborative review and full integration with leading publishing solutions.
• Awareness on QUMAS solutions built-in electronic signatures, audit trail (FDA 21 CFR Part 11), role-based permissions and controlled access to all content and processes available on SharePoint 2010, Documentum, Oracle & SQL Server.

Key Skills:

QUMAS, Life Sciences, Regulatory, FDA 21, CFR Part 11, SQL, Documentum, Oracle