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Document Controller
3 months ago
Job Summary
Great opportunity to work for an Australian multinational specialty biotechnology company.
Supports the maintenance of global quality system processes, procedures, and operational activities related to Quality Assurance oversight of the Document and Records Management Systems which includes, but is not limited to, Document Management, and Application of Global Quality Policies & Standards.
Provide EDMS technical support, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements, and the Seqirus Quality Manual requirements.
- Onsite in Parkville 3 days a week (the rest from home).
- Standard business hours with occasional late or early meeting times
- Initial 9 months contract***
Accountability
Support Document Management Processes
- Perform as EDMS Document Coordinator including:
- workflow and effective document management for Controlled Documents
- notifying staff of new, revised, and withdrawn controlled documents.
- troubleshooting workflows and report generation
- formatting when required.
- Periodic review workflows, reporting, and support.
- Projects to support the EMDS system, eArchive System, or Quality department.
- Support site and function audit preparations with respect to EDMS/eArchive functionality.
- Actively participate in team meetings.
- Supports delivery of document management author training
- Manage documentation for EDMS (Enterprise Document Management System)
Skills Required:
- General knowledge of regulatory requirements for the pharmaceutical, biotechnology, or vaccine industry.
- Pharma Industry experience preferred.
- Ability to analyze issues and problemsolve to support decisionmaking.
- Excellent interpersonal effectiveness, written/verbal communication, influencing, and negotiation skills.
- Ability to work independently.
- Excellent computer skills and advanced knowledge of Quality Systems. Direct experience with TrackWise, EDMS systems, and Microsoft Office including Word and Excel.
- Selfmotivator with the ability to follow up on and complete multiple projects simultaneously.
- Highly attentive to details and able to work well as part of a team.
Knowledge criteria
- Experience with electronic management systems for documents, specifically Documentum preferred.
- Bachelor's degree and 1+ years' experience in a GxPregulated environment within the industry, or equivalent.
Bachelor's Degree requirement
- Life Sciences: Tertiary quals
- Science, Engineering allows for a deeper understanding of documents.
