29.09.2026 aktualisiert
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GMP Consultant: Aseptic Manufacturing, Annex 1, Tech Transfer, QA & QRM | Pharmacist
Innsbruck, Österreich
Deutschland +2
Master of Pharmacy (Mag. pharm.), University of Innsbruck, Austria, 2016info: Deutschland, Österreich, Schweiz
Über mich
Pharmacist and GMP consultant, 10 years in pharma (8 in manufacturing and quality, 6 at Novartis in aseptic production). Annex 1 gap assessments, isolator transfer, media fills, tech transfer, CAPA, QRM, GAMP 5 validation of SaaS and AI. AGES-certified Herstellungsleiterin.
Skills
Good Manufacturing PracticesSaasValidierungsprotokolleGerätequalifizierungGmp-gerechte DokumentationPharmaproduktion
EU GMP Annex 1 & Contamination Control Strategy
Expertise in gap assessments against EU GMP Annex 1, contamination control strategy authoring and implementation, isolator and RABS operations, cleanroom qualification, environmental monitoring concepts, and media fill programme design and investigation.
Aseptic Process Design & Technology Transfer
Hands-on experience in sterile filtration strategy and validation, aseptic process design and troubleshooting, transfer of products and lines between sites and to CDMOs, scale-up of sterile bulk and parenteral processes, and authoring of master batch records and SOPs.
Quality Risk Management (ICH Q9) & Validation
Proficiency in quality risk management to ICH Q9, deviation, complaint and CAPA systems, root cause investigations, change control, audit and authority inspection readiness, supplier qualification, and compliance and validation of computerised, digital and AI-supported applications (GAMP 5).
Media Fills & Sterile Filtration
Practical experience in designing and executing media fill programmes and sterile filtration strategies for aseptic manufacturing processes.
Deviations, CAPA & Change Control
Management of deviations, complaints, corrective and preventive actions (CAPA), and change control processes in regulated pharmaceutical manufacturing environments.
GMP Audits & Inspection Readiness
Support and preparation for GMP audits and authority inspections, including real-time shopfloor support and immediate corrective actions.
Advanced Drug Delivery (Liposomes, Micro- & Nanoparticles)
R&D background in nanoparticle and liposome formulations for antigens and oligonucleotide therapeutics, as well as 3D printing of drug delivery systems.
Supplier Qualification & Requirements Review
Supplier qualification processes and requirements review within regulated GMP and software environments.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2025
Sprachen
DeutschMutterspracheEnglischverhandlungssicherItalienischgut
Projekthistorie
Annex 1 gap assessments, contamination control strategy and implementation support for sterile manufacturing sites. Aseptic process design and troubleshooting including media fills, sterile filtration, isolator and cleanroom operations, technology transfer and scale-up. Quality risk management to ICH Q9, deviation, complaint and CAPA systems, change control, and audit and inspection readiness. Compliance and validation of digital and AI-supported applications in the GMP environment; supplier qualification and requirements review. Scientific and technical due diligence on early-stage life science assets for investors and founders.
Established quality and compliance processes for a regulated software environment: document management, change control, requirements review, supplier qualification and validation activities. Translated GMP, ICH Q9 and contamination control requirements into software requirements and risk assessment methods for a Quality Risk Management platform used in aseptic production. Subject matter expert on Annex 1 compliance and risk-based process evaluation for development teams and pharmaceutical clients; contributed to VR-based training solutions for aseptic production and cleanroom environments.
Led the transfer of a conventional filling line to isolator technology within the site's Annex 1 implementation, coordinating cross-functional teams to operational readiness; designed and executed pre-use small-batch testing to secure reliable product release. Operational expert for the reinstallation of an aseptic bulk manufacturing plant, enabling microparticle R&D scale-up. Subject matter expert for sterile filtration and media fill design; performed Annex 1 gap assessments for aseptic processes and cleanroom operations. Led root cause investigations, deviations, complaints and CAPAs; owned change control, authored master batch records and SOPs. Real-time shopfloor support and immediate corrective actions; supported audits and authority inspections. Led a team and provided 24/7 on-call cover for the aseptic area.
Zertifikate
Herstellungsleiterin
AGES2023
Approbationsurkunde Apothekerin
Landesregierung Oberbayern2017