Agnes Lukacs Email & Phone Number

Hörby, Skåne Län, Sverige

Malmö, Skåne, Sverige

Roles; QA Engineer, QA Support, QA SpecialistResponsibility:- Nonconformity management- Complaint investigations- CAPA and CAPA effectivity checks- Product release- Product and component traceability,- Participating at external and internal inspection- Education of personnel in valid procedures and regulations- Compilation of KPI trend reports regarding to process and product quality- SAP system for daily work- HACCP, BRC regulations for Food Industry, ISO 13485, EC Regulation 1223/2009 (Cosmetics), EU Medical Device Regulation (MDR)

Lund, Sverige

Responsibility:• Inspection of incoming material and product batch protocols • Nonconformity management• Participating in CAPA investigations• Handling and reporting deviations to responsible suppliers • Operating SAP system for daily work • Compilation of KPI trend reports regarding to process and product quality

Malmö, Sverige

Malmö, Sverige

Responsibility: • Functionality tests on the company's patented technology regarding to patient studies,• Lab analyses (e.g. FTIR, IR spectrophotometry, IR camera image analysis)• QMS (ISO 13485) and extern revision.• Networking during conferences to seek new partners for optimizing the usability of the company’s technology.

Lund, Sverige

Responsibility: • Project and sub-project management• Product and process verification, validation • Lead and coordinate change matters from a development perspective to implementation into production.• Technical discussions with internal and external suppliers in collaboration with purchasing and production department• Assisting the complaint department with technical support and investigations.• God knowledge and understanding of Design Control and regulatory requirements for medical device products (ISO 13485); • Preparation and support for FDA inspection, • Development of packaging of powders and products in liquid form• Development and maintenance of test routines, • Participation in the development and maintenance of quality routines and project management.

Lund, Sverige

Responsibility:• Performing, developing, and validating existing and new test methods for hygienic/microbiological evaluations of the company's new and modified dialysis products according to current standards (including GLP) and other valid regulations,• Supporting the QC laboratory and performing hygiene control tests in production. • Evaluation and monitoring of Gambro's RO water purification system via water sampling at various hospitals around Scandinavia.• Participation in development project with responsibility for mapping biofilm in dialysis machines using light microscopy.• Toxicology analysis, performing and evaluating cell tests on new or modified plastic materials for evaluation of risks due to blood exposure during dialysis.

Lund, Sverige

Responsibility:• Development of new microbiological analysis method for cheese rennet,• Verification, validation and implementation of new filter material for rennet production process• Perform QC analysis on product components and finished products• Manufacturing and packaging of various microbiological substrates, nutrient media in production according to current regulations

Bachelor'S Degree, Chemical Engineering

2003 Diplomerad Massör

2002 - Industrial Hygiene And Product Safety 5P, Lth Lund

2000 - Cellens Biologi Och Kemi 10P, Cell Och Mikrobiologi