Brig, Valais, Switzerland
QA professional with a PhD and 10+ years across Tier-1 CDMO, CMO, and CRO environments in Switzerland and Europe. Currently acting FvP at Lonza AG, with profile formally notified to Swissmedic. Responsible for GMP batch release of APIs and BDS on behalf of the Responsible Person, and Quality Lead across multi-million CHF CDMO programs spanning 5+ functional quality streams. One of few QA professionals combining peer-reviewed scientific publication (Algal Research, 2018) with hands-on GMP batch release accountability. PhD in Molecular Genetics, Albert-Ludwigs-Universität Freiburg. MSc in Molecular Biology, University of Pisa (patent filed). Expertise: GMP/GLP · Batch Release (Annex 16/AMBV) · CAPA & Deviation Management · Audit Management · Cross-functional Leadership.
Single point of contact for quality assurance topics within multi-million CHF CDMO program. Involved in custome and regulatory audits. Responsible for batch release activities on behalf of the Responsible Person (FvP/QP). - Release of GMP products (API, BDS) on behalf of the Responsible Person (QP/FvP), in accordance with article 4, 5, and 7 AMBV. - Support during audits for cleaning and production related topics. Approval of MAC-plan, QC plan and release of cleaning protocols. - Quality Lead and SPOC for QA within a cross-functional CDMO project team; coordinating 5+ functional quality streams o ensure timely execution of quality tasks and achievement of project milestones. - Contact with the client for changes, deviations and quality topics; negotition of quality agreements; accompany auditors during customer audits. - Assessment, review and release o quality records (CR, DR, CAPAs). Co-jointly responsible for the initial assessment of DR and leads of execution of DRB. - Review and release of master process/cleaning protocols, PAR List, SOP, master recipes.
Member of the consulting group "Consultys" engaged in quality assurance and quality support for pharma companies in Switzerlnd. - Responsible for project specific and cleaning related QA topicsfor GMP products manufactured in the bioconjugates facilities. - Review of the CQP and qualificatio documents for new facilities, utilities and equipmet. - Review and release of Master cleaning protocols, process descriptions, confirmatin plans and parameter lists. - Review and release ofmaster production protocols; checked compliance of relevant documents (LA, NDA, CMC, DMF, etc.). - Assessed and approved reevant change requests; reviewed and assessed deviatins with respect to GMP requirements. - Supported prouction and QC in cleaning process topics; reviewed adit trails and MAC and QC plans.
Member of the quality organization of the new site.Involved in site commissioning and qualification actvities to ensure quality oversight and compliance wih the company's QMS. - Created, reviewed and approvd SOPs to ensure site compliance with company QMS an current regulations. - Handled deviations and/or unexpected quality events in collaboration with dedicaed departments. - Managed QMS data, policies, record and issues to ensure and maintain quality levels. -Trained site stakeholders on quality-relevant topics ensured all personnel were adequately trained. - Acively supported QC laboratories qualification by revewing and approving URS, QPP and equipment installaton. - Supported Engineering in review and approval of comissioning, technology transfer, qualification and vlidation documentation. - Ensured supplier qualification in accordance with global policies and regulations (ISO9001, CFR 21).
Endotoxin expert. In charge of the correct documentation for unexpected deviation, change request and implementation of analytical method.
Responsible for the scientific part of projects within QClaboratories. Ensured compliance of methods with thelaw and provided scientific support to operators andcustomers. - Subject Matter Expert (SME) within theQC laboratories for biochemistry, bioassay and microiology. - Ensured compliance of methods with GMP phamaceutical requirements (USP, EP, JP, ISO9001, GMP/GP). - Responsible for management of unexpected qualiy deviations, change requests and CAPAs related to sientific activities within QC laboratories and prodution processes. - Responsible for verification and vlidation of analytical methods and transfer from donr laboratories. - Provided scientific support for Project Leaders, QA and Regulatory Affairs. - xperience in GMP software: LIMS, TrackWise, iLAB.
Specialist for the execution of ImmunoHistoChemistry assay, in situ hybridisation and PCR assays. My daily duties include the maintenance and the logistic of the IHC and molecular laboratories. I have to prepare and present the results of the work on regular basis to the project manager and provide accurate report about the experiments according to the ISO, GLP and GMP practice.