Senior Medical Consultant
- Verfügbarkeit einsehen
- 2 Referenzen
- 80‐110€/Stunde
- 2161 Csomad
- Europa
- hu | en | de
- 01.10.2024
Kurzvorstellung
Auszug Referenzen (2)
"B. T. has been a key support in defining a new sterilisation and sterile packaging assurance concept."
2/2022 – 9/2023
Tätigkeitsbeschreibung
Gap analysis for sterilisation and sterile packaging
Coordinate the sterile barrier system developments
Risk analysis of the sterilisation and sterile barrier system
Define the sterilisation strategy of new products
Prepare the sterilisation and sterile packaging process validation plan
Prepare the sterilisation and sterile packaging Design Verification plan
Create sterile packaging standard implementations and summary document
Coordinate sterilisation and sterile packaging validation and verification
Define the packaging test methods and create test descriptions
2
Define the proper machines and tools for packaging tests
Calculate the EO residual limits after sterilisation for new products
Define microbiological limits (CFU limits) for new products
Define endotoxin test frequency and limits
Define physical contamination test frequency and limits
Ingenieurwissenschaft, DIN EN ISO 13485, Verpackung und Kennzeichnung
"It is easy to work with Balázs.
Balázs' main strengths:
- diverse knowledge
- manliness
- helpfulness
- result orientation
- professionalism"
9/2018 – 10/2019
Tätigkeitsbeschreibung
R&D responsible for wound drainage and suction devices
Substitute of the Head of Development Center in his absence
R&D responsible for medical device packages, whole portfolio produced on site
Coordinate projects, capacities and delegate tasks within the R&D group
DIN EN ISO 13485, Verpackungstechnik, Ingenieurwissenschaft
Qualifikationen
Projekt‐ & Berufserfahrung
8/2023 – 1/2024
Tätigkeitsbeschreibung
Gap analysis of sterile barrier system
Prepare the sterile barrier system bench testing plan: including extreme
environmental conditioning, shipment simulation, packaging and functional tests
Define the necessary unique distribution cycle (DC 2 according to ASTM D4169)
proper for the planned logistics
Define climate conditioning parameters depending on target market
Create sterile packaging standard implementations and summary document
Coordinate the bench testing process.
Define the packaging test methods and create test descriptions
DIN EN ISO 13485, Prozessvalidierung, Verpackung und Kennzeichnung
2/2022 – 9/2023
Tätigkeitsbeschreibung
Gap analysis for sterilisation and sterile packaging
Coordinate the sterile barrier system developments
Risk analysis of the sterilisation and sterile barrier system
Define the sterilisation strategy of new products
Prepare the sterilisation and sterile packaging process validation plan
Prepare the sterilisation and sterile packaging Design Verification plan
Create sterile packaging standard implementations and summary document
Coordinate sterilisation and sterile packaging validation and verification
Define the packaging test methods and create test descriptions
2
Define the proper machines and tools for packaging tests
Calculate the EO residual limits after sterilisation for new products
Define microbiological limits (CFU limits) for new products
Define endotoxin test frequency and limits
Define physical contamination test frequency and limits
Ingenieurwissenschaft, DIN EN ISO 13485, Verpackung und Kennzeichnung
10/2020 – 2/2022
Tätigkeitsbeschreibung
Coordinate the daily work of the engineering and maintenance team (10 employees)
Ensure continuous production
Improve manufacturing process, implement LEAN concepts
Validation of new processes and equipment
NPI – transfer newly developed products/machines into the production
DIN EN ISO 13485, Verpackungstechnik, Management (allg.)
10/2019 – 10/2020
Tätigkeitsbeschreibung
Optimisation of production process with plant simulation software
Real Time monitoring of material flow and production
Simulation, implementation and monitoring of material handling with AGVs
Clarify relevant customer requirements about the product
Market research for possible customers
Business Analysis
9/2018 – 10/2019
Tätigkeitsbeschreibung
R&D responsible for wound drainage and suction devices
Substitute of the Head of Development Center in his absence
R&D responsible for medical device packages, whole portfolio produced on site
Coordinate projects, capacities and delegate tasks within the R&D group
DIN EN ISO 13485, Verpackungstechnik, Ingenieurwissenschaft
9/2016 – 9/2018
Tätigkeitsbeschreibung
found in reference description 5
R&D responsible for wound drainage and suction devices
R&D responsible for medical devices packages produced on site
Packaging optimisation – define new materials, harmonise current portfolio
Coordination of packaging Process Validations and Design Verification based on ISO
11607-1/2
Development of new, crystal clear drain bottles with tube set to the US market
Supplier Audit – external lab
Ensure the clean water supply for production
Define frequency of testing and the sampling points of the clean water system
Prepare URS for new production equipment
Revise specifications and drawings of supplier.
DIN EN ISO 13485, Ingenieurwissenschaft, SAP CRM, Verpackungstechnik
9/2015 – 9/2016
Tätigkeitsbeschreibung
R&D responsible for wound drainage and suction devices
Development of new, crystal clear drain bottles to the US market
Implement new back check valve to drain bottles
Revise specifications and drawings of supplier
Verification of new components from alternative supplier
Ingenieurwissenschaft, Verpackungstechnik
Ausbildung
Budapest Business School
Budapest
Budapest Univercity of Technology and Economics
Budapest
Budapest University of Technology and Economics
Budapest
Über mich
Weitere Kenntnisse
Certificates and trainings:
▪ ISO 13485; ISO 13485 – internal auditor
▪ Medical device packaging (ISO 11607-1 and -2; ASTM F1980, ASTM F1886,
ASTM1929, ASTM F88, ASTM F2096, EN 868-5, EN 868-10)
▪ Transport simulation (ASTM D4169)
▪ Microbiology and sterile barrier system (ISO 15378, DIN-58953-6; DIN EN ISO 10993-
1, ISO 10993-5, ISO 10993-7)
▪ Sterilisation (EN ISO 11737-1 and -2; EN 14644; EN 556-1 and -2; ISO 11135; EN ISO
14161)
▪ Member of the organisation: ASTM (American Society for Testing and Materials)
▪ Project management
▪ 4DX and 7 Habits (Franklin Covey)
▪ EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC) (MDD)
▪ Regulation (EU) 2017/745 (MDR)
▪ Agile project management
Persönliche Daten
- Ungarisch (Muttersprache)
- Englisch (Fließend)
- Deutsch (Fließend)
- Europäische Union
- Schweiz
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