Sep 16, 2022

Job Description

-Manage cost effective GxP Compliance and/or Audit activities, operations and systems to ensure compliance of business areas with the Novartis Quality Manual and Policies and all relevant GxP, legal and regulatory requirements, and through internal audits, KPIs (Key Performance Indicators) and KQIs (Key Quality Indicators). -Performs preparation and management of external and corporate audits and Health Authority inspections.
-Planning and supporting PQR/APQR activities. -Support site qualification and validation activities (planning, advising, review). -Implementation of Quality Systems (incl. documentation management) -Supplier management activities (agreements, oversight, audit). -Preparation/support & coordination of CAPA/follow-up -Audit and inspection preparation and support -Change control review/approval -Ensure local DI & eCompliance oversight (training, inspections, plan, risk ID etc) -Ensure process quality assurance acc. to regulations -QP declaration review and approval -KPI trending -Ensure applications, certificate maintenance etc. to local HA -SPOC for communication with HA, GCA / One voice / consolidated approach / synergies for all sites within same HA jurisdiction / country -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) QA oversight in all GMVC related activities and in Gebze 2 QC laboratory&AST&SCM (Warehouse activities) PQR system management Quality Plan preparation&follow up Global procedures implementation follow up (QM/QD/GOP/GS etc) QA oversight in Gebze 2 QC laboratory Transport deviation handling Transport Risk Assessment preparation, QMS spoc Deputy: Documentation system CONDOR, eSOPS, superuser for SAP

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

People Leadership Project Management Collaborating across boundaries Functional Breadth English Regulatory Compliance Risk Management Knowledge of GMP Inspection Preparedness Knowledge of all people management and development process and practices Quality decision making Knowledge of IT Applications & tools Effective communication Quality Assurance
Novartis Technical Operations
Full Time
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Senior Quality Compliance Coordinator.

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