Basel, Basel, Switzerland
Interested and experienced in GDP and GMP compliance & Quality Assurance of pharmaceutical and medical device industry including ● all tasks of a Responsible Person (EU) and FvP (CH) in pharmaceutical companies ● Implement, maintain and update an adequate quality system ● Preparing, receiving and follow-up of Inspections by Health Authorities ● Performing Supplier Audits and Self-inspections ● Batch Release, Product Quality Reviews ● Deviation & CAPA Management ● Complaint & Recall Handling, Field Action Investigation ● FDA 21 CFR 820, ISO 13485, MDD 93/42/EEC ● Liaising with internal and external partners or Health Authorities ● Communication tasks and negociations with scientific arguing ● Optimizing processes and Implementing new processes
• Batch Release of approx. 60 Human and 90 Anmal Health Products incl. vaccines • Optimizing the batch release process • Proceeding deviations and CAPAs • Contributing to the inspection readiness for the 2-days-inspection by Health Autorities • Planning and execution of the Qualification of Transport Quality System / Transport Validation
• Assuming all responsibilities of a Responsible Person and Head Quality Assurance • Preparation/conducting inspections of local Health Authorities (CH / EU) • Audits at the Contract Manufacturers and Logistic Service Providers (CH / EU) • Updating QMS-system, creation or revision of SOPs • Establishing ICH Q3D Risk Assessments on Elemental Impurities • Serialisation Project (Falsified Medicine Directive 2011/62/EU & Reg (EU) 2016/161) Responsible Person (FvP) of Sanofi Pasteur MSD AG, Baar ZG (12.2015 - closure 12.2016) • Assuming all responsibilities of a Responsible Person for vaccines • Prepared, conducted and followed-up a Swissmedic inspection • FvP of MSD Vaccines, Luzern up to the closure in 06. 2017 01.-11.2015 Consultant Assignments as Senior QA Specialist, Novartis Pharmaceuticals, Stein AG and Stryler GmbH, Selzach SO • Batch Release of packaging material and specific Medical Device components (inhalators) • Addressing CAPA, deviations, OOS and further quality issues ensuring compliance with current regulations of FDA, EMA, Swissmedic, ISO and internal company policies • Supplier Quality Management, NCRs, TrackWise training
Complaint Handling / Field Action Investigation (04 - 12.2014) • Technical evaluations for field action investigations including direct interface to Quality department, manufacturing sites, Product Development, Regulatory Affairs and Post Marketing Risk Management • Compliance with current regulations of FDA 21 CFR 820, ISO 13485, MDD 93/42/EEC, Swissmedic and internal company policies • Identifying problematic situations, performing SAP/EtQ Searches, Root Cause Analysis, conducting and reviewing product complaint investigations, reporting issues, developing resolutions and decision making • Internal and external communication, presentations, telephone conferences (WebEx) Supplier Quality (06.2013 - 03.2014) • Review and resolution of 300 supplier related non-conformances (NCRs) of production plants • Upgraded SOP's / work instructions to comply with FDA 21 CFR 820 / MDD 93/42/EEC requirements • Training of internal personnel in several production sites on supplier quality processes including requirements of FDA’s 820.90 Non Conformance Management • Evaluating and reporting of supplier performance metrics (audits, complaints, CAPAs, NCs)
- Quality assurance management and implementation of GxP regulations - Processing complaints and quality defects, - Release of products, established the PQR, updated SOPs - Contact with relevant Health Authorities (Swissmedic, BAG) and with opinion leaders - Sales Meetings / Training of employees - Marketing and medical/scientific management of established Rx products - Potential analysis and planning of the introduction of new nutraceuticals
- Quality assurance management , implementation of GxP regulations - Organized internal GxP trainings for employees, established PQR, updated SOPs - Contact with Health Authorities (Swissmedic, BAG) including 2 audits - Liaised with associations, opinion leaders, patient organisations - Answering medical/scientific questions and technical complaints to customers, sales force and distributors worldwide - Analysed available scientific studies and upcoming publications - Production planning based on forecasts and market analysis