Basel, Basel, Switzerland
Corporate Quality Management Consulting in Life Sciences, focused on MedTech, Pharma and Logistics / GDP. Areas of Expertise: 1. Quality System Compliance: Gap assessments, improvements for effectiveness & efficiency (including Management Responsibilities / Management Review, Risk Management, CAPA & Complaint Management, Post Market Surveillance, Validation, Design Control, Supplier Management, Logistics / GDP). Internal & External Audits / Audit Programs / Supplier Audits (ISO 9001, ISO 14001, ISO 13485, ISO 14971, ISO 15378, ISO 22716, GMP / GDP). Support for Inspection Readiness / Mock Audits (cGMP; US FDA 21CFR820 / 210 / 211; Health Canada/CMDCAS; ANVISA; KFDA; MHLW, others). Training programs for GMP/GDP & Quality System Compliance. 2. Regulatory Consultancy: Global Regulatory Planning. Medical Devices & IVDD Registration (incl. CE readiness). Design Dossier Examinations / Technical Documentation (STED).
Pharma-, Medical Devices-, Cosmetics-Supplies / Pharmaceutical Packaging / Syringes. Customer Quality, Technical Quality, Quality Management, Quality Control. Responsibility for the Quality Management System (ISO 13485, ISO 15378, ISO 9001, GMP/GDP), Quality Planning, Quality System Management Reviews, Quality Reporting, Audit Programs (internal and suppliers), Complaint Handling and Product Vigilance, Risk Management, Quality Training & Education, supplier development, Qualification/Validation/Calibration and Metrology, Document Management & CAPA Systems, supply chain quality & disposition, validation, environmental monitoring. Quality Management Representative (QMB).
Medical Devices & Systems / implant, restorative and regenerative dentistry. Global responsibility for Quality Management, including multiple manufacturing-, development-, distribution-sites and local affiliates with distribution responsibilities. Conformance to FDA/QSR 21CFR820, EU regulations, GMP/GDP, ISO 9001, ISO 13485 (CMDCAS), ISO 14001, JPAL, ANVISA others). Corporate Compliance & Auditing, Quality Systems & Documentation, Design & Product Compliance, Field Quality Assurance/Vigilance & CAPA.
Medical Devices / Diabetes Care, Insulin Infusion Systems. Responsibility for the Quality Management System (FDA/QSR 21CFR820, ISO 13485/CMDCAS, ISO 9001) incl. Quality Planning, Quality System Management Reviews, Quality Reporting, Regulatory Affairs (product registrations Class I/II/III devices). Product / Process / Site compliance with focus on FDA/QSR, GMP/GDP and EU Medical Device Directives. Interaction with legal bodies, competent authorities, audit programs, inspection readiness, compliance training, design control quality, risk management. complaint handling and vigilance.
In-vitro Diagnostics Medical Devices & Systems. Responsibility for Quality Management Systems of European production, Global logistics sites and International Regulatory Affairs (incl. FDA-QSR, GMP/GDP, EU IVDD, ISO 13485 (CMDCAS), ISO 9001 & others). Field Quality Assurance & Vigilance, Auditing (internal, affiliates & suppliers), CAPA Systems, Documentation Management Systems, Process Control & Statistics.