This position exists as a member of the Global R&D QA department assisting the R&D QA Quality Systems organization with management of the Document Management Systems (DMS) activities to support the R&D Quality Management System.
The Senior R&D QA Associate will be responsible for the overall content and maintenance of the DMS system on behalf R&D Quality and will coordinate document management workflow activities for personnel supported by the R&D Quality Systems organization. Providing support for global R&D and QA organization in GXP compliance related matters, including assurance that all aspects of procedural document management comply with GXPs, legal, regulatory requirements, and CSL Quality Manual requirements.
Reporting to the Manager R&D Global Document Management Systems.
Key Responsibilities
* Collaborate with global R&D functions to ensure their DMS needs are captured as required, participate in DMS initiatives, and create consistency across the CSL R&D organization.
* Liaise with other procedural document management contacts to share best practices and identify/leverage opportunities across Quality systems and processes.
* Manage procedural documents and associated documents in the DMS by: Providing Subject Matter Expert (SME) advice/assessments on procedural document management, Publishing and routing the approval of GxP procedural and associated documents in the DMS, Ensuring that properties are assigned to documents in a compliant manner, Facilitate document change control, Maintain procedural document templates for R&D, Monitoring document effective dates and facilitate periodic review/update as required, Basic system troubleshooting
* Support internal audits and regulatory inspections through providing readily accessible records from the DMS
* Provision of Quality KPI metrics related to procedural document management. This may also include follow up with document owners to ensure review and update of documents on a timely basis
* Stay current with industry trends and contribute innovative ideas to enhance the overall DMS experience
* Support the Head, R&D Quality Systems / Manager, R&D Global Document Management Systems in day to day activities as required
Skills & Experience
1. University degree in in a relevant business, communication, technology, science discipline or equivalent education or experience
2. Experience in use and administration of Document Management Systems (DMS)
3. Pharmaceutical industry experience in Quality, or R&D environment
4. Knowledge of industry regulations; with emphasis on GxP guidelines
5. General understanding of quality systems and appreciation of need for regulatory compliance
6. Ability t