Salvador Petanas Esteban

Chemist with a master’s degree in Advance Organic Chemistry at UB, expert in the instrument qualification and computerized system validations following the GMP’s, 21CRF and ISO guidelines and documentation in different areas such as QC, QA, Production and Engineering, confident, and versatile. Analytical Instrumentation and Computerized System Validation (CSV) expert with proven organisational, communication, teamwork and coordination skills. Willing to further develop my professional career in a renowned company.

Ambit BST – Barcelona, Spain
Validation Manager (Boehringer Ingelheim)
[ 01/11/2024 – Current ]
• Ensure that appropriate validation activities are carried out to comply with the validation planning and
applicable prior to system operation.
• Ensure all system specific SOPs and SLC documentation are in place prior to the operation phase.
• Ensure the validated state of the system is maintained once the system is operational.
• Advise System Leads and teams on the creation and execution of IT changes.
• Monitor compliance with corporate IT regulations.
• Use of GMPs, 21CFR and ISO guidelines and documentation
• Change control, CAPA and incidence management
• Audit participation as Validation Manager
• Standard Operating Procedures edit and review.
• Planification and execution of computerized system validations in compliance with the current regulations
• Creation of system validation relate documentation.

Kymos S.L. – Barcelona, Spain
Analytical Instrumentation and CSV Coordinator
[ 01/07/2023 – 01/11/2024 ]
• Implementation and validation of computerized systems
• Evaluation of the laboratory departments needs
• Acquisition of new laboratory equipment
• Use of GMPs, 21CFR and ISO guidelines and documentation
• Change control, CAPA and incidence management
• Audit participation as site IT validations Specialist
• Standard Operating Procedures edit, review and approve
• Planification and execution of computerized system validations in compliance with the current regulations
• Creation of CSV relate documentation: Validation Master Plan, Risk Assessment, Installation, Operational and Performance qualification protocols, reports and traceability matrix.

Laboratorios Reig Jofré – Barcelona, Spain
Quality Assurance Technician – IT Validations
[ 01/01/2017 – 01/07/2023 ]
• Implementation and validation of serialization computerized systems
• Implementation and validation of electronic quality management system (Trackwise)
• Implementation and validation of electronic documentation management system (MyQUMAS)
• Use of GMPs, 21CFR and ISO guidelines and documentation
• Change control, CAPA and incidence management
• Audit participation as site IT validations Specialist
• System administration of laboratory systems
• Standard Operating Procedures edit, review and approve
• Planification and execution of computerized system validations in compliance with the current regulations
• Creation of CSV relate documentation: Validation Master Plan, Risk Assessment, Installation, Operational and Performance qualification protocols, reports and traceability matrix.
• Participation in the implementation of a new manufacturing line for parenteral products
• Management and coordination of project activities as representative of Quality assurance in the project meetings with future customers of the new line
• Participation in site Quality Indicators definition and report of these indicators to the management
 

Laboratorios Reig Jofré – Barcelona, Spain
Quality Control Technician – Analytical Instrumentation Technician
[ 01/11/2014 – 01/01/2017 ]
• System administration of laboratory systems
• Standard Operating Procedures edit, review and approve
• Documentation review and update
• Change control, CAPA and incidence management
• Maintenance and Qualification of laboratory equipment’s
• Creation of equipment qualification documentation (VMP, IQ, OQ, PQ)
• Management of external qualifications / calibrations
• Contact with the supplier to verify offers and services
 

Institut de Quimica Avançada de Catalunya (CSIC) – Barcelona, Spain
PhD Researcher
[ 01/02/2008 – 01/02/2014 ]
• Member of the project “Una aproximación integral al desarrollo de tecnologías para detectar residuos de antibióticos de uso veterinario para mejorar la eficacia de control desde la granja a la mesa (PANOPTES)”
• Member of the project “Desarrollo y demostración de nuevas tecnologías para la detección de residuos de antibióticos de uso veterinario a lo largo de la cadena de producción de alimentos de origen animal. Control y seguridad de los alimentos desde la granja a la mesa (DETECTA)”
• Member of the project “Sistemas de detección y cuantificación de biomarcadores de la enfermedad de Alzheimer

Almirall Prodesfarma – Barcelona
Internship
[ 01/01/2007 – 01/11/2007 ]
• Maintenance and Qualification of equipment’s
• Creation of equipment qualification documentation (VMP, IQ, OQ, PQ)
• Documentation review and update
• Change control, CAPA and incidence management
• Preventive activities

Master’s Degree in Advance Organic Chemistry
Universitat de Barcelona [ 01/02/2008 – 01/02/2009 ]
 

Chemistry Degree (Organic Chemistry)
Universitat de Barcelona [ 01/09/2000 – 01/01/2008 ]