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

University degree in in a relevant business, communication, technology, science discipline or equivalent education or experience

Experience in use and administration of Document Management Systems (DMS)

Pharmaceutical industry experience 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

Ability to interact, communicate and work with colleagues globally

Proven experience in coordinating training and learning programs

High attention to detail & strong customer focus

Ability to work independently and as a team member

Planning and co-ordination

Written and oral communication skills, German language skills required

Proficiency in document management systems, Veeva QDocs preferred

This role can be based in Zurich or Bern

Hybrid - 50% office based

About CSL Vifor

CSL Vifor aims to become the global leader in iron deficiency and nephrology.

The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

For more information, please visit viforpharma.com

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