Ester Villarrubia Email & Phone Number

Basel, Bs, Ch

Basilea-Ciudad, Suiza

• Develop implement and maintain QMS management strategy and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organisation's annual business plan and long-term strategy as a Legal Manufacturer, Australian Sponsor and European Importer.• Ensure compliance with the Post-Market Surveillance obligations and Risk Management.• Liaise and co-operate with Notify Bodies, Minister of Health (MoH), Customers, Suppliers, Subcontractors, Distributors, European Representative and UK Representative. • Implement Regulation to maintain internal certification of ISO13485:2016 and MDSAP such as Australia • TGA, Brazil - ANVISA, Japan - MHLW/PMDA, USA-FDA, and MDR 2017/745. Lead Auditor.• Wordlwide Countries Lisence Renewals and Submission of Medical Devices Portfolio including but not limited: USA, Japan, China, Canada, Australia, Switzerland, Great Britain (UKCAmarking), LATAM (Brazil. Mexico, ....), Middle East (Egypt, Iran, Israel,..), ROW.• Ensure Team Management, review performance, set objectives and perform annual review.

Cork, Condado De Cork, Irlanda

Risk Mitigation:• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.Product/Process Qualification: • Approve IQ, OQ, PQ, TMV or Software ValidationStrategic:• Ensures effective quality strategies are created for the validation of test methods, process and design.Product Quality, Control & Disposition and Performance Standards:• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.Business Improvements• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.

España

• Creating the QMS and ensure implementation and maintenance of the global quality standards for obtaining the ISO 13485 certification for the migration of 3 companies, 200 stores and headquarter. • Ensure localization & implementation of quality processes (Supplier & Legal Manufacture Control, recalls, product realization, ISO14971-Risk Management, etc....), as per regulatory and QMS requirements. • Run & coordinate internal and external quality and regulatory audits.• Comply with the current CD 93/42/EEC, the futur MDR 2017/745 and the RD 1591/2009 National Regulation.

Barcelona Y Alrededores, España

• Management the project to restructuring the Industrial Plant, Logistics, Laboratory, IT and QMS in order to obtain the ISO 22716 and comply with 1223/2009 EC and 85/2018 RD cosmetic product.• Implementation of the certification obtained in April 2018 by SGS.• Cosmetovigilance, Ecologic certifications, licenses, Clinical Studies and Claims.• Internal and External Audit, Risk Analysis, Training, Supplier Evaluation, Third Manufacturing.• Quality Manual, SOPs, CC, NCR, Deviation, Equipment Qualification. • Artworks, Labeling and Packaging Supervisor. • Other related with the quality system, production and logistics.• Management the quality team.

Barcelona Y Alrededores, España

• Management of worldwide country registrations (renewals & launches) in LATAM, ASIA & EAME. • Risk Assessment, Market Surveillance, PMA, Customer Survey.• Technical File, Licenses, relation with the Ministry of Health (AEMPS) and regulatory bodies. • Provide regulatory & quality support to Clinical Trials, Sales, MKT and Logistics departments.• Documentation to submit at the ethics committee of the hospital. (Custom Made)• US (FDA) and EU regulations knowledge, International laws. CE mark.• Able to support regulatory inspections• Review design (R&D), assembly and finished product to release to the market.• Audits, CAPA, NCR, Policy, SOP, DHR, Complains, Change Controls, Trainings, SuppliersSuppliers, QMS. • Labeling and Packaging Supervisor.• Management the quality team.

Barcelona Y Alrededores, España

• Audits, CAPA, non-conformities, claims, change controls, training.• SOP´s, Policies, Instructions Laboratory, Analytical Methods, manufacturing methods, specifications. • Supplier certification, CoA's, Artworks, OOS. IQ-OQ Laboratory Equipment. Master Validation.• Laboratory Analysis adequacy to meet the ISO 13485 and ISO 22716 certification.• Protocols and reports Stability Studies and other related with the department.• Support to industrial scale-up and R&D.

Barcelona Y Alrededores, España

• Check the manufacture and packaging in production lines. (Oncology, Antibiotics, Psychotropic,...).• Labeling and Packaging Supervisor.• Documentation Review batch for release to the market in compliance with 2001/83/EC, Regulation (EC) 726/2004 and GMP.• Audits, NCR, Change Control, SOP, Artworks, Specifications, Deviations, Complaints, KPI's.• Sampling and Documentary archives of samples.• Analytical methods: HPLC, TD, IR, UV, KF, pH and titrations, among others. Calibrations.

Barcelona Y Alrededores, España

• Reviewing and approval of Raw Material and Packaging Material.• Studies tinctures tissue autoclaves pilot plant (manufacture scale up).• Product Review packaging line.• Microbiological analysis: planting and plaque counts.• FQ analysis of MP, intermediate and finishing. Include: KF, pH, Viscosities, others.

Biomedical Engineering (Master)

Medical Sales Techniques & Psychology (Master), Selling Skills And Sales Operations

Business Administration Master (Mba), Business Administration And Management, General

Health Sciences Degree (Psychology), Health Services/Allied Health/Health Sciences, General

Food Qc Technician, Chemistry

Chemical Technical Specialist Hnd (Uk) = Cfgs (Spain), Chemistry

Clinical Health Care Hnc (Uk) = Cfgm (Spain)

Children & Young' Activities Director, Education