Experience

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  Gsk

  Jun 2015 - Sept 2018

  -Investigation of Complaints and Deviations through the implementation of tools for root cause analysis (Gap analysis, Fishbone, 5 Why, Line of sight).-Implementation of Corrective and/or preventive actions in manufacturing areas.-Monitoring of quality systems, aligned with current procedures, to improve current indicators, reaching established target values ​and maintaining them over time.-Management of Change Controls.-Management of TrackWise System, Quality Work Flow-Generation and editing of Operating Procedures.-Implementation of GPS (GSK Production System) - GEMBAs, 5S, Problem Solving, Process Confirmation.-Knowledge of pharmaceutical manufacturing technology, GMP and EHS Standards-Participation as Co-Auditor in internal L1 and L2 audits in different sectors Show less

  • Manufacturing Supervisor

    Oct 2017 - Sept 2018

  • Excellence in Deviation Management Champion Coach

    Jun 2016 - Aug 2018

  • Quality Systems Analyst

    Jun 2015 - Oct 2017
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  Laboratorio elea

  Sept 2018 - May 2020

  Tech transfer leader

  -Manage of pilot batches and placebos of solid, semi-solid and liquid pharmaceutical forms.-Support and monitoring of production batches.-Generation of transfer and scaling up protocols and reports.-Writing of manufacturing guides and operating procedures.-Management of deviations, CAPAs and change controls

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  Gsk

  May 2020 - Apr 2021

  Manufacturing supervisor

  -Leader of manufacturing and packaging process of effervescent salts (Alikal, Uvasal, ENO, Andrews products)-Assistance in the processes related to the production and packaging of effervescent salts and associated documentation, following the guidelines of the Quality Management System, Internal Process Improvement Systems, Occupational Safety and local and international regulatory standards.-Supervision of the different production teams that make up the work area.-Confirm the standards required to manage safety, quality, regulatory compliance and productivity.-Lead/Coordinate Root Cause Analysis (Problem Solving)-Coach personnel in charge. Improve operator capabilities and performance.-Participate in the organization and control of self-inspections of each process, ensuring compliance with audit plans Show less

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  Bayer pharmaceuticals

  Apr 2021 - May 2022

  Manufacturing supervisor

  - Management of Solids Processing and Fractionation personnel- Monitoring of the Production plan (Berocca, Redoxon, Supradyn, Paracetamol, Pronatal products)- Control of EHS standards according to work area- Opinion of production orders- Control of fractionation processes, aqueous and alcoholic granulation, dry mixtures, compression and coating according to standards and regulatory procedures- Monitoring and formulation of deviations- Ensuring compliance with GMP standards- Procedures management- Participation in internal audits and cleaning validations Show less

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  Laboratorios bernabo s.a.

  Jun 2022 - Jan 2024

  Qa coordinator

  -Review and follow-up of deviations, CAPAs, change controls, OOS-Management of staff training-Supervision of the review of Batch Records-Review of SOPs, standards, internal documentation-Complaint management-Internal and external audits-RAP management-Release of finished product (solid, liquid FF, creams, emulsions, pastes, syrups, injectables)

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  Esteve

  Apr 2024 - now

  Global quality pharma - quality manufacturing senior specialist

  -Management of Quality Assurance activities related to CMO operations to ensure GMP compliance.-Review and approval of batch manufacturing instructions, analysis methods and specifications, change controls, deviations, out-of-specification (OOS) and out-of-trend (OOT) records.-Review and approval of Stability Protocols.-Supplier/CMO quality monitoring based on business risk assessment.-Continuous evaluation of supplier/CMO operations and recommendation of operational and quality improvements.-Management of supplier/CMO metrics, KPIs and trend reports.-Management of Product Quality Reviews (PQRs) from CMO, support in the final review and compilation of PQRs.-Support in the generation of QTAs and in the preparation of Audits. Show less