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QA eCompliance Expert (m/f/d)



Legal, Quality Assurance
Posted on Friday, May 26, 2023
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!

Together we will shape the future of Sandoz… are you ready to make a difference?

As a QA eCompliance Expert (m/f/d) you will be responsible for the compliance and Quality Assurance support of the GxP computerized systems including supplier quality assessment/management throughout their lifecycles in regards to the applicable regulations and requirements defined in the Sandoz Quality Manual and procedures. eCompliance provides guidance on CSV related topics and related information. Reviews and/or approves the qualification and operational deliverables of respective GxP computerized systems. Provides guidance and support of the development of business processes in scope GxP systems and support QA and eCompliance strategic activities as assigned in accordance with the law, internal regulations, good practices and business objectives.

Your key responsibilities:

Your responsibilities include, but not limited to:
• Ensure all activities in compliance with cGxP, incl. data integrity.
• Support site qualification and validation activities (planning, advising, review).
• Audit and inspection preparation and support.
• Ensure local DI and eCompliance oversight (training, inspections, plan, risk ID etc.).
• Provide quality assurance expertise / guidance for GxP computerized systems classification, qualification, supplier assessment, change control, deviation management and associated activities that ensure compliance to regulatory and company expectations.
• Review and approve determination of computerized system for GxP applicability.
• Maintain close relationship with the applicable Regional eCompliance Expert(s) and perform timely support for projects, inspections and audits.
• Perform life-cycle activities of the GxP laboratory computerized systems in scope (e.g.: periodic reviews, change controls, deviations management, risk mitigations) including review & approval of relevant documentation and its maintenance according to the Sandoz requirements.