Kerstin Haberecht

Global Quality Systems Process Owner PQR & Network

- Set up, lead and coordinate integration projects for IT Systems and related processes for DR/CAPA Management, Change Control, Documentation and Training - Establish effective governance and reporting structures - Participate and lead steering committees - Continuous improvement of Quality Systems - Responsible for communication and change management for the implementation/integration of new systems and processes - Assure compliance with national/international and internal requirements and regulations

- Set up, lead and coordinate integration projects for IT Systems and related processes for DR/CAPA Management, Change Control, Documentation and Training - Establish effective governance and reporting structures - Participate and lead steering committees - Continuous improvement of Quality Systems - Responsible for communication and change management for the implementation/integration of new systems and processes - Assure compliance with national/international and internal requirements and regulations

Responsible for the prep, organization and follow-up activities of the NVx Leadership team and the NV divisional Quality Committee, prep of executive mngt meetings for the Global head of Quality, incl the NVx Executive Committee, tracking of Quality action items and facilitate pre-read packages, monthly reports into Group and compilation of the Novartis vaccines divisional Monthly report, support of the Global head of Quality in preparation of various steering commitees and organizational matters

International Assignment, Part of Quality Excellent Program Method Evaluation Lead, Establish external laboratory to transfer Method Validation, Lead Method Validation Remediation Projects, Projects: Lean Labs, Warehouse Transition

Responsible for the compliance of the products and manufacturing process regarding GMP standards and licensed specifications. Assistant Supervision together with the team the Batch Record Review, Supervision of the Deviation system of the functional Area and approval of investigation reports and ensures that adequate CAPAs are defined, Supports manufacturing of biologic and sterile products. From May 2013 - October 2014 part of 18-month Quality Excellence Program

Management von DRs und CAPAs, Projektarbeit

Management von Abweichungsmeldungen, Management von Change Controls, Koordination und Bearbeitung von APRs (Jahresberichten), Projektmanagement, Batch Record Review und Vorbereitung der Chargenfreigabe

Validierung einer neuartigen Messmethode, Unterstützung der Produktentwicklung

Qualitätssicherung, Analytik (IR, GC,HPLC, Potentiomentrie, RFA)

Qualitätssicherung, Qualitätskontrolle, Analytik