Alicia Fernández Ruiz
Morges
Summary
Qualified Person under Directive 2001/83/EC and 2001/82/EC with over 10 years of experience in the pharmaceutical and medical device industries, including 8 years in management roles. Currently serving as Quality Assurance Manager and Production & Supply Chain Coordinator at Veldana Medical (Exeltis Group), leading QMS implementation and maintenance under ISO 13485 and EU MDR 2017/745, managing technical documentation, regulatory interactions, post-market surveillance, and cross-functional coordination with contract manufacturers and suppliers.
Strong expertise in medical device regulatory compliance, clinical investigations under ISO 14155, GMP/GDP environments, and pharmacovigilance systems (GVP). Proven track record in liaising with Health Authorities, Notified Bodies, CROs, and international partners, ensuring regulatory compliance across the product lifecycle.
Overview
11
11
years of professional experience
Work History
Production and Supply Chain Coordinator
Veldana Medical (Exeltis Group)
Morges
07.2025 - Current
- Coordinates day-to-day production activities to meet delivery schedules and customer demand.
- Analyse production data to identify opportunities for improvement and maximize available resources.
- Supervision and ongoing training of production operators.
- Oversees the end-to-end movement of materials, ensuring regulatory compliance.
- Coordinate with contract manufacturers and suppliers to ensure timely availability of raw materials and finished goods.
Quality Assurance Manager
Veldana Medical (Exeltis Group)
Morges
04.2022 - Current
- Maintenance of technical file according to ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, ISO 11135 ISO 11607-1, ISO 11607-2.
- Good knowledge/understanding of the EU Medical Device Regulation (EU) 2017/745 and European Medical device Directive 93/42/EEC.
- Interlocution with Sanitary Authorities and notified bodies.
- Support in medical devices registration or promotion requirements in Europe or international level.
- Implementation & Maintenance of QMS.
- Responsible for the management of Device Complaints and the surveillance and monitoring of medical devices in the market.
Project Manager PMFC investigation study
Veldana Medical (Exeltis Group)
Morges
01.2024 - 04.2025
- Coordinate all activities relative to post market follow up clinical investigation under GCP.
- Assure compliance with ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice.
- Interlocution with all the partners involved in the clinical investigations as CRO, Hospitals, investigators, consultants, ethic committees and Sanitary Authorities.
Qualified Person under the provision of Directive 2001/83/EC and Directive 2001/82/EC
Oxigen Salud Group
Barcelona
03.2017 - 04.2021
- Assurance programs GMP; GDP; ICH; ISO 9001; ISO 14001; ISO 13485.
- Interlocution with sanitary Authorities and notified bodies.
- Collaborating and approving validation and qualification required for the manufacture and distribution of drug (manufacture process, software validation and validation of transport).
- Supervising and signing the approval of the annual product quality review reports (PQR), as well as the Technical Agreements with the Customers and Suppliers.
Qualified person for Pharmacovigilance (QPPV)
Oxigen Salud Group
Barcelona
10.2018 - 11.2020
- Assurance programs GVP;
- Case assessment and processing, coding with MedDRA, database management (ArisG, ARGUS, Clintrace).
- SOPs & WI writing, PSUR ASR and other safety report writing.
- Bibliographic searches, safety agreements, signal detection and labelling activities.
- Communication with health professionals and Regulatory Authorities.
Scale up and Tech Transfer Technician
Laboratorios Isdin
Barcelona
03.2016 - 03.2017
- Formulation of final products in cosmetics (shampoo, creams, mouthwashes, toners, etc) and evaluations of properties.
- Evaluation of preservative systems.
- Writing of manufacturing protocols, laboratory instructions and reports.
- Designing of laboratory studies.
- Cooperating in the validation of manufacturing processes.
- Industrial Scale up (Lleal, Bachiller, JM Andres, Becomix...).
- Pilot Scale up (Pilot reactor Becomix RW30).
- Transfering of manufacturing and validation instructions.
Formulation Scientist
Laboratorios Salvat
Barcelona
01.2015 - 12.2015
- Formulation of pharmaceutical, healthcare and cosmetic products.
- Developing preliminary and final dosage form including oral, topical, ophthalmic and otic formulations.
- Devising scale-up process; providing standard operation procedures and standard operation instructions.
- Presenting and reporting technical results, providing scientific interpretation of data.
- Preparing technical documentation to support development work and manufacturing (includes laboratory notebooks, batch records and process validation documentation, SOP) to internal, customer and regulatory requirements.
- Designing of experiments (DoE) and quality by design (QbD).
Education
MSc - Pharmaceutical Development and Pharmaceutical Industry
University of Barcelona
Barcelona2015
MSc - Molecular Biotechnology.
University of Barcelona
Barcelona2009
BSc - Pharmacy
University of Granada
Granada07.2008
Skills
- Pharmaceutical and medical device legislation expertise
- Quality management systems
- Pressure resilience
- Confident judgment
- Decisive action
- Detail-oriented results focus
- Accuracy and completeness emphasis
- Independent work proficiency
- Tight timeline management
- Multi-priority handling
- Fast-paced environment adaptability
Languages
Spanish
First Language
English
Advanced
C1
French
Upper Intermediate
B2
References
References available upon request.
Interests
✈️ Viajar
🤿 Bucear
🚴 Bicicleta
Timeline
Production and Supply Chain Coordinator
Veldana Medical (Exeltis Group)
07.2025 - Current
Project Manager PMFC investigation study
Veldana Medical (Exeltis Group)
01.2024 - 04.2025
Quality Assurance Manager
Veldana Medical (Exeltis Group)
04.2022 - Current
Qualified person for Pharmacovigilance (QPPV)
Oxigen Salud Group
10.2018 - 11.2020
Qualified Person under the provision of Directive 2001/83/EC and Directive 2001/82/EC
Oxigen Salud Group
03.2017 - 04.2021
Scale up and Tech Transfer Technician
Laboratorios Isdin
03.2016 - 03.2017
Formulation Scientist
Laboratorios Salvat
01.2015 - 12.2015
MSc - Pharmaceutical Development and Pharmaceutical Industry
University of Barcelona
MSc - Molecular Biotechnology.
University of Barcelona
BSc - Pharmacy
University of Granada