R&D Procedural Document Specialist
vor 4 Wochen
As R&D Procedural Document Specialist, you will be 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.
You will manage the 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.
You will provide 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.
You will report to the Global Head of R&D Quality Systems • Quality.
Your role and responsibilities
You will collaborate with global R&D functions to ensure their DMS needs are captured, participate in DMS programs, and create consistency across the CSL R&D organization. You will collaborate with other procedural document management contacts to share best practices and identify opportunities across Quality processes. You will manage procedural documents and associated documents in the DMS You support internal audits and regulatory inspections through providing accessible records from the DMS. You will provision of Quality Measurements related to procedural document management. This may also include follow-up with document owners to ensure review of documents. You stay current with industry trends and contribute ideas to enhance the DMS experience. You support the Head, R&D Quality Systems / Manager, R&D Global Document Management Systems in daily activities.Your education and experience
University degree in in a relevant business, communication, technology, science discipline or equivalent education or experience. Min 1-year experience in use and administration of DMS. Pharmaceutical industry experience of at least 1-year in Quality, or R&D environment. Knowledge of industry regulations; with emphasis on GxP guidelines. General understanding of quality systems and appreciation of need for regulatory compliance Fluent in English
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you.
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