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Job ID 211731BR Position Title GMP Quality Manager (80%) - 24 month temporary assignment Division PHARMA Business Unit Region Europe GenMed Country Switzerland Work Location Rotkreuz Company/Legal Entity Novartis Pharma Schweiz AG Functional Area Quality Job Type Part Time Employment Type Temporary Job Description • Implement and maintain the local Quality System in the areas of GMP, GDP and GPvP, in accordance with the Novartis Quality Manual and the CPO Quality Plan.
• Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appropriately in order to mitigate risk.
• Lead and Manage assigned projects and business operations regarding medical devices taking into account all GMP practices and regulatory requirements and in close collaboration with the local digital champion. Provide support to the global Medical Devices Management Team (MDMT) for the global certification of Novartis Pharma for medical devices.
• Responsible for the release of product batches and related packaging materials in close cooperation with the QA GMP and Development Manager as delegated by the Responsible Person.
• Review documentation of incoming batches of medicinal products, and market actions, Review customer, supplier and product master data, Review records of returned goods.
• Review relevant global and local Product Quality Reviews (PQRs).
• Deviation Management: Ensure that deviations and issues are properly managed in Track wise System AQWA including the respect of the escalation process. Participate in QA Investigation activities, as appropriate.
• Conduct vendor assessment and/or qualification visits for locally outsourced GxP activities in close collaboration with QA GMP and Development Manager.
• Provide support prior to, during and after HA inspections and internal audits of the CPO and external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPs have been completed/closed. Minimum requirements • PhD or Master Degree in Chemistry, Pharmacy or equivalent
• Minimum 2-3 years’ experience in the pharmaceutical industry in a relevant field such as Quality Assurance, Quality Control, Registration, Clinical Development or a directly related area
• Medical devices and IT projects experience
• German and English fluent in speaking and writing, knowledge of French desired
• Knowledge of local regulatory requirements, GMP and ICH guidelines.
• Computer skills: MS Office, experience with SAP and Track Wise.
• Good understanding of IT product development processes in regulated environment.
• Excellent problem identification and solving skills.