Ana B. Ramos Rayón
Madrid
Summary
Accomplished Quality Manager with a proven track record at Head Solutions S.L, enhancing regulatory compliance and operational improvements. Expert in SAP and cross-departmental coordination, I spearheaded initiatives that significantly uplifted quality system management, leveraging Agile methodologies for continuous improvement.
Overview
15
15
years of professional experience
Work History
Quality Manager
Head Solutions S.L and Mercados y Comercios Asiáticos S.L
Madrid
11.2022 - Current
- Implementation of different Quality System Managements (ISO, FSSC22000, GRS, IWAY)
- Engaged with regulatory authorities, partners, clients, and suppliers.
- Lead internal and external audits, securing high standards.
- Managed complaints and non-conformities effectively.
- Coordinated homologation processes for suppliers.
- Upheld standards for GRS and ISO 9001 certification.
- Provided leadership in developing best practices for continuous improvement initiatives across all departments.
Technical Responsible person and GDP Coordinator
Italfarmaco Medilab S.A
Madrid
01.2020 - 11.2022
- Enhanced and sustained Quality System and associated records.
- Facilitated initial and ongoing training.
- Coordinated quality agreements with suppliers and partners.
- Liaised regularly with key Regulatory Authorities and stakeholders.
- Conducted comprehensive risk assessments.
- Execute comprehensive audits adhering to GMP/GDP standards.
- Ensured medicine traceability through efficient serialization.
- Developed more efficient warehouse processes.
- Supervised logistics to resolve quality issues.
- Managed and tracked resolution progress for all complaints and incidences.
- Oversaw homologation and ongoing monitoring of providers, third parties, clients.
- PQR management, collaboration, and quality issues.
Pharmaceutical Technical Director and Quality Responsible Department
Lozano Transportes SAU
Madrid
09.2016 - 12.2019
- Complied with GDP regulations for medicinal products and medical devices.
- Acted as a communication conduit for drivers, suppliers, staff and clients.
- Oversaw and executed tasks to finalize CAPA actions.
- Managed validation schedule skillfully.
- Carry out internal and external audits (ISO 9001, recertification and Pharmaceutical clients)
- Drafted and revised Quality documentation, addressing change controls, formularies, standard procedures nonconformities.
- Sought out, connected with, and negotiated terms with service suppliers.
- Implemented project worth 7 million euros to enhance FARMA service processes.
- Trained, monitored, and followed up on GDP compliance.
- Verified third-party adherence to specified standards.
- Analyzed performance metrics to recommend optimizations for enhanced system efficiency.
Community Pharmacist
Speedwell Pharmacy
Hemel Hempstead
04.2016 - 09.2016
- Dispensed medications, provided patient counseling, and managed stock and inventory.
- Oversaw administrative management including formula mastery and handling of psychotropic and narcotic medications.
Warehouse and logistics technician
Abbott Medical Optics
Alcobendas
03.2012 - 09.2015
- Overseeing inventory intake and recording data in system.
- Coordinated dispatch and exports delivery with transport companies and ensured timely completion of all deliveries.
- Facilitate project deadlines through effective coordination and management.
- Collaborated with IT in Santa Ana, California to resolve incidents.
- Oversaw data accuracy, keeping all entries timely and thorough.
- Overseeing work orders, requisitions, transfer orders, and adjustments.
- Established effective collaboration between carriers, suppliers, planners and personnel.
- Searched and negotiated with service providers assuring the cost efficiencies.
- Managed reconciliation of transport expenses and liaised with logistics operators.
- Monitored and managed rates effectively (KPIs, temperature, transport invoices...)
- Managed and directed the development of CR's.
- Led CAPA activities to timely completion.
- Generated and revised warehouse documentation including change orders, formularies, and non-conformities.
- Supervised warehouse personnel training.
- Maintained schedule for equipment calibration and work order management.
Data Analyst PRM Global Chinese and Portuguese Market
IMS Health
Madrid
08.2011 - 12.2011
- Categorising different products, updating patents, ensuring quality assurance of data and production management
Technical Director and Regulatory Affairs Assistant
Shire Pharmaceuticals Ibérica S.L
Madrid
01.2010 - 12.2010
- Controlled stocks and shipments for Spanish and Portuguese markets.
- Maintained regular communication with suppliers, clients, and regulatory bodies.
- Supported and supervised all departments to meet quality and compliance goals.
- Aided in development and management of GMP and GDP QA systems.
- Evaluated and authorized SOP documents submitted by other departments for Quality Assurance purposes.
- Spain and Portugal quality documents checking and batch release
- Delivered weekly updates to Customer Services team in the UK.
- Guaranteed compliance of labels, leaflets, and cartons with relevant legislation.
- Monitored changes and updates.
- Crafted high-quality AEMPS, Farmaindustria and CAM communications.
- Ensured compliance with Code of Good Practices and Spanish and Portuguese regulations for patient and doctor materials.
- Maintained consistent updates to clients' database.
- Monitored sales data and provided reports to the Sales Manager.
- Overseeing hospital and customer orders.
Education
Expert - Regulatory Affairs in Medicines and Medical Devices
EPHOS/AEFI
01.2022
GDP - for medical devices
AEFI
01.2021
GMP audits -
CPM
01.2020
Good distribution practices course -
AEFI
01.2020
Technical Responsible person/Technical Director course -
AEFI
01.2020
Logistics planning and telematic systems and control -
Centro Cesur
01.2018
GDP Warehouse audits -
CPM
01.2016
MBA -
Centro de Estudios empresariales Euroinnova
01.2011
Master - International Management and Marketing in Pharmaceuticals Companies
CESIF
01.2010
Pharmacy Degree -
Salamanca University
01.1999
Project Management I and II -
FEMXA
Skills
- Microsoft Office
- SAP
- ZINC
- Agile
- Dataview
- Continuous improvement
- Cross-departmental coordination
- Training and development
- Problem solving
- Project management
- Supplier relationship management
- Operational improvements
- Measurement system analysis
- Quality system management
- Regulatory compliance
Languages
- English, Advanced
- Spanish, Native
Personal Information
Driving License: Full driving car license
Timeline
Quality Manager
Head Solutions S.L and Mercados y Comercios Asiáticos S.L
11.2022 - Current
Technical Responsible person and GDP Coordinator
Italfarmaco Medilab S.A
01.2020 - 11.2022
Pharmaceutical Technical Director and Quality Responsible Department
Lozano Transportes SAU
09.2016 - 12.2019
Community Pharmacist
Speedwell Pharmacy
04.2016 - 09.2016
Warehouse and logistics technician
Abbott Medical Optics
03.2012 - 09.2015
Data Analyst PRM Global Chinese and Portuguese Market
IMS Health
08.2011 - 12.2011
Technical Director and Regulatory Affairs Assistant
Shire Pharmaceuticals Ibérica S.L
01.2010 - 12.2010
Expert - Regulatory Affairs in Medicines and Medical Devices
EPHOS/AEFI
GDP - for medical devices
AEFI
GMP audits -
CPM
Good distribution practices course -
AEFI
Technical Responsible person/Technical Director course -
AEFI
Logistics planning and telematic systems and control -
Centro Cesur
GDP Warehouse audits -
CPM
MBA -
Centro de Estudios empresariales Euroinnova
Master - International Management and Marketing in Pharmaceuticals Companies
CESIF
Pharmacy Degree -
Salamanca University
Project Management I and II -
FEMXA
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