Address
Form of work8 to 10 years of experience in QUMAS 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. (1.) To ensure process compliance in the assigned module, and participate in technical discussionsorreview as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations). (2.) To develop and guide the team members in enhancing their technical capabilities and increasing productivity (3.) To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.
(4.) To be responsible for providing technical guidance or solutions ;define, advocate, and implement best practices and coding standards for the team.
