Luisa Zoque

Experience

• 

  Novartis Pharma Produktions GmbH

  Sept 2006 - Jul 2015

  - Process responsibility for globally distributed pharm. packaged Products, including product batch release- Design and roll-out responsibility for multiple cleaning and process validations - Process responsibility for transfer and start-up activities. - Monitoring and continuous improvement of the processes with coordination of cross functional teams - Product Responder in health authority inspections - Project lead responsibility for the conception and construction of new QC Labs for a product transfer (Investment 0.5 Mio EUR)- Roll-out responsibility for cleaning and process validations - Responsibility for meeting the daily business goals of the production area (8 Mio Tubes per year/ 50 operators)- Lean Six Sigma Green Belt certification Project management responsibility of multiple infrastructure and production projects (up to 0.5 Mio EUR/year)

  • Maternity leave

    Jul 2013 - Jul 2015

  • Process Expert (Head of Manufacturing according to the Geman law)

    Sept 2011 - Jun 2013

  • Project Manager

    Feb 2010 - Aug 2011

  • Production team leader – Coordinator

    Jun 2008 - Jan 2010

  • Project Engineer

    Sept 2006 - May 2008
• 

  Merck Group

  Aug 2015 - now

  Managing key product quality topics during the lifecycle of biotechnology medicines, from development until discontinuation. Supporting manufacturing sites, subsidiaries and other entities to ensure the efficient handling of product quality risks and issues. I'm in charge of coordinating QA aspects related to process validatîon, such as:-Lead of QA activities including definition of Validation Master Plan, approval of protocol and reports, risk assessments-Review and approval of deviations and changes, lead investigations-Establishment of process control strategy-Lead the definition, implementation and follow-up of the validation program

  • Quality Management Systems and Compliance Associate Director

    Dec 2023 - now

  • Site Regulatory Compliance Manager

    Nov 2022 - Dec 2023

  • Global Product Quality LIfeCycle Manager

    Feb 2020 - Oct 2022

  • Associate Manager QA Process Validation and Cell Banking

    Jun 2019 - Jan 2021

  • Associate Manager QA Process Validation

    Nov 2018 - Jan 2021

  • QA Validation Engineer

    Aug 2015 - Nov 2018