Tímea Rófusz is an analytical chemist seeking a position where she can utilize her 9 years of experience. She has worked at several pharmaceutical companies developing and validating chromatography methods. At her current role at TEVA, she introduced a new GC software and proposed a better sampling swab. She has participated in FDA and Hungarian Health Authority inspections with no findings. Rófusz received her MSc in Instrumental Analytical Chemistry in 2014 and has published 3 papers and presented posters on analytical topics.
BOC Sciences Updated Its Product Catalog of Pharmaceutical Impurity Reference...BOC Sciences
BOC Sciences recently updated its product list of pharmaceutical impurity reference standards to better serve pharmaceutical companies, scientific research units, testing institutions and universities. Visit https://www.bocsci.com/products/impurities-8.html for more information.
Chemical Characterization of Plastic Used in Medical ProductsSGS
Dr. Andreas Nixdorf presented on chemical characterization of plastics used in medical products according to ISO 10993 standards. He discussed the normative framework for chemical characterization and analytical methods for identifying extractables and leachables. Key points included sample preparation according to ISO 10993-12, using both exaggerated and accelerated extraction conditions. A variety of analytical techniques were outlined for separation and detection of extractable substances.
This document discusses coding technologies used to combat counterfeit pharmaceuticals. It describes overt coding methods like size, shape, and logos but notes these can be copied. Covert coding uses chemical or physical markers added invisibly. Regulatory barriers have hindered adoption of coding technologies but guidelines from the FDA have helped. Cost is also an issue, especially for generic drug makers. Future solutions may use nanotechnology and mobile phone verification to authenticate drugs for patients and ensure the correct personalized formulation.
Innovative Hospital Partnership Model for High Quality Patient Clinical TrialsSGS
This document describes an innovative hospital partnership model for high quality patient clinical trials in Central and Eastern Europe. Specifically, it discusses a case study of an oncology trial involving a partnership between SGS, a clinical research organization, and hospitals in the region. The key aspects of the model include SGS establishing satellite patient units within selected hospitals to increase access to patients while maintaining functional ownership over trial operations. This allows SGS to leverage its clinical expertise and quality systems to successfully execute trials at these partner hospital sites. The document then provides details on an existing partnership in Belgium and a proposed partnership for a satellite unit in Hungary to support oncology trials across Central and Eastern Europe.
1. The pharmaceutical development process has low success rates, with less than 1 in 100,000 compounds tested making it to consumers and only 3 in 10 drugs earning back their average R&D costs.
2. Big pharma spends most of its R&D budget on late-stage clinical trials and regulatory costs. Outsourcing is increasingly used to access new technologies and markets.
3. The presentation discusses ChemRar's experience partnering with over 1200 companies globally over 20 years to conduct outsourced R&D and develop drugs through various stages from target identification to clinical trials.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
Anjireddy Kolla has over 10 years of experience in analytical research and development. He holds an M.Sc. in Organic Chemistry from Andhra University and has worked as an Application Scientist at Thermo Fisher Scientific and Agilent Technologies, providing support on method developments and instrument operation. Currently, he seeks a challenging position utilizing his skills in chromatography, mass spectrometry, method development and validation.
BOC Sciences Updated Its Product Catalog of Pharmaceutical Impurity Reference...BOC Sciences
BOC Sciences recently updated its product list of pharmaceutical impurity reference standards to better serve pharmaceutical companies, scientific research units, testing institutions and universities. Visit https://www.bocsci.com/products/impurities-8.html for more information.
Chemical Characterization of Plastic Used in Medical ProductsSGS
Dr. Andreas Nixdorf presented on chemical characterization of plastics used in medical products according to ISO 10993 standards. He discussed the normative framework for chemical characterization and analytical methods for identifying extractables and leachables. Key points included sample preparation according to ISO 10993-12, using both exaggerated and accelerated extraction conditions. A variety of analytical techniques were outlined for separation and detection of extractable substances.
This document discusses coding technologies used to combat counterfeit pharmaceuticals. It describes overt coding methods like size, shape, and logos but notes these can be copied. Covert coding uses chemical or physical markers added invisibly. Regulatory barriers have hindered adoption of coding technologies but guidelines from the FDA have helped. Cost is also an issue, especially for generic drug makers. Future solutions may use nanotechnology and mobile phone verification to authenticate drugs for patients and ensure the correct personalized formulation.
Innovative Hospital Partnership Model for High Quality Patient Clinical TrialsSGS
This document describes an innovative hospital partnership model for high quality patient clinical trials in Central and Eastern Europe. Specifically, it discusses a case study of an oncology trial involving a partnership between SGS, a clinical research organization, and hospitals in the region. The key aspects of the model include SGS establishing satellite patient units within selected hospitals to increase access to patients while maintaining functional ownership over trial operations. This allows SGS to leverage its clinical expertise and quality systems to successfully execute trials at these partner hospital sites. The document then provides details on an existing partnership in Belgium and a proposed partnership for a satellite unit in Hungary to support oncology trials across Central and Eastern Europe.
1. The pharmaceutical development process has low success rates, with less than 1 in 100,000 compounds tested making it to consumers and only 3 in 10 drugs earning back their average R&D costs.
2. Big pharma spends most of its R&D budget on late-stage clinical trials and regulatory costs. Outsourcing is increasingly used to access new technologies and markets.
3. The presentation discusses ChemRar's experience partnering with over 1200 companies globally over 20 years to conduct outsourced R&D and develop drugs through various stages from target identification to clinical trials.
The document is a presentation by Obaid Ali on microbiology and pharmaceutical transformation. It discusses topics like clinical trials, new and generic drug manufacturing, vigilance, research, microbiology, human safety and efficacy verification, quality claims, consistency, contamination, surveillance, and signals from vigilance. Ali has experience working at the FDA and Health Canada and is currently leading scientific transformation initiatives at DRAP and advising the Centre for Quality Science.
Anjireddy Kolla has over 10 years of experience in analytical research and development. He holds an M.Sc. in Organic Chemistry from Andhra University and has worked as an Application Scientist at Thermo Fisher Scientific and Agilent Technologies, providing support on method developments and instrument operation. Currently, he seeks a challenging position utilizing his skills in chromatography, mass spectrometry, method development and validation.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
Amarish Kumar Sharma is an Indian national currently residing in Copenhagen, Denmark. He has over 10 years of experience in research and development, working on projects related to metabolic disorders like diabetes. He has worked as an Assistant Professor, Research Scientist for various companies and institutions in India. His educational qualifications include a Master of Technology in Biotechnology and Bachelor of Technology in Biotechnology.
This document contains a summary of Mehul D. Patel's work experience and qualifications. It lists his current role as a Research Associate at Torrent Pharmacuticles Ltd since 2006, where he conducts bioanalytical activities and drug metabolism/pharmacokinetics research. Previously he worked as a Research Associate at CADILA Pharmaceutical Ltd from 2005-2006 developing and validating analytical methods. He has a M.Pharm in Pharmacology and B.Pharm degree, and has over 15 years of experience in bioanalytical method development and validation using LC-MS/MS and HPLC techniques.
This curriculum vitae is for Marion Schimpgen, a French national with over 10 years of experience working in chemistry laboratories and the pharmaceutical industry. She has a Master's degree in Forensic Toxicology and a Bachelor's degree in Applied Science and Forensic Investigation. Her most recent role is as a Technical Regulatory Document Specialist at Roche in Basel, Switzerland, where she prepares regulatory documents for health authorities and supports regulatory processes.
Patrick Flanagan has over 15 years of experience in formulation development, analytical chemistry, and quality control. He currently works as a Principal Research Associate at Genzyme, a Sanofi company, where he supervises multiple employees and has hands-on experience in cGMP operations. Flanagan has led cross-functional teams, coordinated meetings and resources, and represented his department at internal and external conferences. He has extensive experience characterizing and developing formulations for various protein therapeutics.
Adrian Vasquez has over 13 years of experience as an analytical chemist and biopharmaceutical scientist, specializing in stability testing and quality analysis using instrumentation such as UPLC, ICP, and HPLC. He mentors new chemists, maintains inventory, and ensures efficient workflow and a safe lab environment. Vasquez is a green belt in six sigma certification and holds an MS in Chemistry from St. John's University.
Sheryl Mondejar Navarra has over 10 years of experience as a medical technologist in hospital settings and 2 years in an allergy laboratory. She has experience operating a wide range of automated instruments and maintaining quality control. She is skilled in troubleshooting issues, releasing results, and coordinating laboratory finances. She seeks new opportunities to utilize her expertise in medical technology.
Brian Lam is seeking a position as a QA officer. He has over 2 years of experience working as a QA officer for Bristol Laboratories in the UK where his responsibilities included sampling and testing materials, approving artwork, batch record reviews, audits, and validation activities. He also did a pharmacy clerkship with Watsons Ltd in Hong Kong. Brian has an MSc in Pharmaceutical Technology from the University of Bradford and a BSc in Pharmaceutical Science from the University of Manchester. He has strong technical skills and interpersonal skills.
Vatinno Rosa has over 10 years of experience working in chemical laboratories. She holds a PhD in Microbiology, Food Safety and Chemistry from the University of Bari. Her experience includes positions as Chemical Lab Manager at Merck Serono S.p.A., Laboratory Coordinator also at Merck Serono S.p.A., and Senior Laboratory Technician. She has strong skills in analytical techniques like solid phase microextraction coupled to chromatography, as well as knowledge of pharmacopeias and laboratory management systems. She is fluent in English and is currently seeking new opportunities.
This document is a resume for Amarish Kumar Sharma, an Indian biotech professional with over 6 years of research experience in drug discovery and development. His experience includes assay development, toxicity studies, high-throughput screening, and research projects related to diabetes, stem cells, and drug screening. He has worked as a research scientist and assistant professor and holds an MTech and BTech in Biotechnology from Bundelkhand University in India.
Venkata Prasad Vemulapally has over 11 years of experience in pharmaceutical quality control and quality assurance. He currently works as an Executive Quality Operations at Mylan Laboratories Ltd, where he is responsible for reviewing chromatography and chemical analyses to ensure compliance with cGMP and USFDA regulations. Previously, he worked as an Analyst in Quality Control at Divi's Laboratories Ltd, where he performed instrumental and chemical analyses of raw materials, intermediates, and finished products. He has extensive experience with HPLC, GC, UV-Vis spectroscopy, FT-IR, and potentiometric titration instruments. Vemulapally holds a Master's degree in Biotechnology and Bachelor's degrees in Chemistry, Botany, and
This document summarizes Shawn Lee's objective of obtaining a scientific position utilizing his training and knowledge in areas like pharmaceutical quality control, research and development, and manufacturing. It lists his technical skills in chromatography, spectroscopy, and immunoassay. It then summarizes his work experience from 1989 to present in analytical roles for companies like Johnson & Johnson, Organon, and Roche, involving tasks like method development, validation, out of specification investigations, and computer systems.
Aida Melendez has over 30 years of experience in the pharmaceutical industry as a chemist, manager, and environmental project manager. She has expertise in areas such as manufacturing operations, quality assurance, laboratory management, and regulatory compliance. She is bilingual in English and Spanish and has a proven track record of managing teams and projects. She holds a B.S. in Chemistry and additional certifications in bioscience technology and quality systems.
Amarish Kumar Sharma has over 6 years of experience in biotech research and academia. He has worked as a research scientist and assistant professor in India and Denmark, focusing on drug discovery and development for diabetes. His experience includes assay development, high-throughput screening, toxicity studies, and university teaching. He holds an MTech in Biotechnology and BTech in Biotechnology from Bundelkhand University in India.
Jagdip K Kooner has extensive laboratory skills and experience in analytical techniques such as chromatography, spectroscopy, and thermal analysis. He has strong problem solving, communication, and project management abilities developed through roles in quality control and assurance. Kooner seeks to apply his skills and experience gained over a decade working in pharmaceutical, chemical, and materials testing industries.
The document provides information about a candidate's skills and qualifications for a position. It includes summaries of their education history with modules completed in areas like DNA analysis and protein purification. It also lists work experience in microbiology and quality control roles. Key skills mentioned are proficiency in lab techniques and IT programs as well as providing private tuition classes. Research projects are summarized covering evaluation of drug regulation in Europe and developing a business plan for a biofertilizer company.
Kristen Beuving has over 15 years of experience in research including analytical chemistry, toxicology, behavioral pharmacology, and microscopy. She has held roles such as executive assistant, weekend group leader, associate study director, research analyst, and research assistant. Beuving has extensive knowledge of FDA and regulatory guidelines and experience managing projects, personnel, and laboratory operations. She has strong leadership, problem solving, and technical skills.
Mr. Sagar Hasabe is seeking a challenging career in biotechnology utilizing his 8 years of experience in quality control. He currently works as an Assistant Manager in quality control at Loba Chemie Pvt Ltd, a certified ISO company, where he oversees laboratory operations and documentation. Previously he has worked at Nuclear Power Corporation and Nu-Life Pharmaceuticals conducting analytical testing and developing new methods. He has a Master's degree in Biotechnology and is proficient in instruments like HPLC, GC, and UV-Vis spectroscopy.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
Thiruneelakandan Gnanasambandan is seeking a challenging position in pharmaceuticals, medical devices, healthcare, or biosciences to utilize his skills in product and method development. He has over 5 years of experience in quality control and R&D, specializing in analytical method validation and transfer. He is skilled in HPLC, GC, UV, and titration methods and has experience managing quality teams and ensuring regulatory compliance. His most recent roles include method transfer specialist and quality control head at pharmaceutical companies in Singapore.
Amarish Kumar Sharma is an Indian national currently residing in Copenhagen, Denmark. He has over 10 years of experience in research and development, working on projects related to metabolic disorders like diabetes. He has worked as an Assistant Professor, Research Scientist for various companies and institutions in India. His educational qualifications include a Master of Technology in Biotechnology and Bachelor of Technology in Biotechnology.
This document contains a summary of Mehul D. Patel's work experience and qualifications. It lists his current role as a Research Associate at Torrent Pharmacuticles Ltd since 2006, where he conducts bioanalytical activities and drug metabolism/pharmacokinetics research. Previously he worked as a Research Associate at CADILA Pharmaceutical Ltd from 2005-2006 developing and validating analytical methods. He has a M.Pharm in Pharmacology and B.Pharm degree, and has over 15 years of experience in bioanalytical method development and validation using LC-MS/MS and HPLC techniques.
This curriculum vitae is for Marion Schimpgen, a French national with over 10 years of experience working in chemistry laboratories and the pharmaceutical industry. She has a Master's degree in Forensic Toxicology and a Bachelor's degree in Applied Science and Forensic Investigation. Her most recent role is as a Technical Regulatory Document Specialist at Roche in Basel, Switzerland, where she prepares regulatory documents for health authorities and supports regulatory processes.
Patrick Flanagan has over 15 years of experience in formulation development, analytical chemistry, and quality control. He currently works as a Principal Research Associate at Genzyme, a Sanofi company, where he supervises multiple employees and has hands-on experience in cGMP operations. Flanagan has led cross-functional teams, coordinated meetings and resources, and represented his department at internal and external conferences. He has extensive experience characterizing and developing formulations for various protein therapeutics.
Adrian Vasquez has over 13 years of experience as an analytical chemist and biopharmaceutical scientist, specializing in stability testing and quality analysis using instrumentation such as UPLC, ICP, and HPLC. He mentors new chemists, maintains inventory, and ensures efficient workflow and a safe lab environment. Vasquez is a green belt in six sigma certification and holds an MS in Chemistry from St. John's University.
Sheryl Mondejar Navarra has over 10 years of experience as a medical technologist in hospital settings and 2 years in an allergy laboratory. She has experience operating a wide range of automated instruments and maintaining quality control. She is skilled in troubleshooting issues, releasing results, and coordinating laboratory finances. She seeks new opportunities to utilize her expertise in medical technology.
Brian Lam is seeking a position as a QA officer. He has over 2 years of experience working as a QA officer for Bristol Laboratories in the UK where his responsibilities included sampling and testing materials, approving artwork, batch record reviews, audits, and validation activities. He also did a pharmacy clerkship with Watsons Ltd in Hong Kong. Brian has an MSc in Pharmaceutical Technology from the University of Bradford and a BSc in Pharmaceutical Science from the University of Manchester. He has strong technical skills and interpersonal skills.
Vatinno Rosa has over 10 years of experience working in chemical laboratories. She holds a PhD in Microbiology, Food Safety and Chemistry from the University of Bari. Her experience includes positions as Chemical Lab Manager at Merck Serono S.p.A., Laboratory Coordinator also at Merck Serono S.p.A., and Senior Laboratory Technician. She has strong skills in analytical techniques like solid phase microextraction coupled to chromatography, as well as knowledge of pharmacopeias and laboratory management systems. She is fluent in English and is currently seeking new opportunities.
This document is a resume for Amarish Kumar Sharma, an Indian biotech professional with over 6 years of research experience in drug discovery and development. His experience includes assay development, toxicity studies, high-throughput screening, and research projects related to diabetes, stem cells, and drug screening. He has worked as a research scientist and assistant professor and holds an MTech and BTech in Biotechnology from Bundelkhand University in India.
Venkata Prasad Vemulapally has over 11 years of experience in pharmaceutical quality control and quality assurance. He currently works as an Executive Quality Operations at Mylan Laboratories Ltd, where he is responsible for reviewing chromatography and chemical analyses to ensure compliance with cGMP and USFDA regulations. Previously, he worked as an Analyst in Quality Control at Divi's Laboratories Ltd, where he performed instrumental and chemical analyses of raw materials, intermediates, and finished products. He has extensive experience with HPLC, GC, UV-Vis spectroscopy, FT-IR, and potentiometric titration instruments. Vemulapally holds a Master's degree in Biotechnology and Bachelor's degrees in Chemistry, Botany, and
This document summarizes Shawn Lee's objective of obtaining a scientific position utilizing his training and knowledge in areas like pharmaceutical quality control, research and development, and manufacturing. It lists his technical skills in chromatography, spectroscopy, and immunoassay. It then summarizes his work experience from 1989 to present in analytical roles for companies like Johnson & Johnson, Organon, and Roche, involving tasks like method development, validation, out of specification investigations, and computer systems.
Aida Melendez has over 30 years of experience in the pharmaceutical industry as a chemist, manager, and environmental project manager. She has expertise in areas such as manufacturing operations, quality assurance, laboratory management, and regulatory compliance. She is bilingual in English and Spanish and has a proven track record of managing teams and projects. She holds a B.S. in Chemistry and additional certifications in bioscience technology and quality systems.
Amarish Kumar Sharma has over 6 years of experience in biotech research and academia. He has worked as a research scientist and assistant professor in India and Denmark, focusing on drug discovery and development for diabetes. His experience includes assay development, high-throughput screening, toxicity studies, and university teaching. He holds an MTech in Biotechnology and BTech in Biotechnology from Bundelkhand University in India.
Jagdip K Kooner has extensive laboratory skills and experience in analytical techniques such as chromatography, spectroscopy, and thermal analysis. He has strong problem solving, communication, and project management abilities developed through roles in quality control and assurance. Kooner seeks to apply his skills and experience gained over a decade working in pharmaceutical, chemical, and materials testing industries.
The document provides information about a candidate's skills and qualifications for a position. It includes summaries of their education history with modules completed in areas like DNA analysis and protein purification. It also lists work experience in microbiology and quality control roles. Key skills mentioned are proficiency in lab techniques and IT programs as well as providing private tuition classes. Research projects are summarized covering evaluation of drug regulation in Europe and developing a business plan for a biofertilizer company.
Kristen Beuving has over 15 years of experience in research including analytical chemistry, toxicology, behavioral pharmacology, and microscopy. She has held roles such as executive assistant, weekend group leader, associate study director, research analyst, and research assistant. Beuving has extensive knowledge of FDA and regulatory guidelines and experience managing projects, personnel, and laboratory operations. She has strong leadership, problem solving, and technical skills.
Mr. Sagar Hasabe is seeking a challenging career in biotechnology utilizing his 8 years of experience in quality control. He currently works as an Assistant Manager in quality control at Loba Chemie Pvt Ltd, a certified ISO company, where he oversees laboratory operations and documentation. Previously he has worked at Nuclear Power Corporation and Nu-Life Pharmaceuticals conducting analytical testing and developing new methods. He has a Master's degree in Biotechnology and is proficient in instruments like HPLC, GC, and UV-Vis spectroscopy.
1. CURRICULUM VITAE
Tímea Rófusz, Phone: +36-20/552-0516, E-mail: rofusz.timea@gmail.com 1/2
Name: Tímea Rófusz
Date of birth: March 1, 1980
Address: 3300 Eger, József Attila u. 52., Hungary
Phone: +36-20/552-0516
E-mail: rofusz.timea@gmail.com
http://www.linkedin.com/pub/timearofusz/
My goal is to became a bioanalytical expert by working in a rewarding environment, where my endeavors count and efforts are
appreciated, and where my 9 years of work experience as an analytical chemist would benefit the company.
ACHIEVEMENTS:
Successful participation in 4 FDA GMP-inspections, 1 Hungarian Health Authority (OGYÉI) GLP-inspection, 11 internal audits;
active participation in audit preparations. In all cases, there were no findings related to my tasks.
Proposed a better sampling swab for the manufacturing plant. During a routine analysis in 2013, I noticed interference in a
cleaning validation method by HPLC/UPLC. The interfering impurity was originated from the swab; I tested different swabs
and proposed a new one for routine use at the TPW-GD site; checked for possible interference in all cleaning validation
methods used on site, and validated the method with the new equipment. The plant is using this new swab ever since.
From 2010 to 2012 I introduced Empower 2, a new measurement software for the GC equipment. All related activities were my
responsibility; creating GC projects within Empower 2, validating GC custom fields within the projects, revising and reissuing all
documentation (method descriptions, SOPs), holding trainings. This system was later audited by FDA.
MAIN ABILITIES:
Great time management skills: excel at multitasking whilst adhering to strict timelines
Able to work independently in a quick but efficient, meticulous manner
Self-development skills: keen learner and comfortable with mentoring colleagues
Exceptional customer focus: always delivers, outstanding organizing skills
Great understanding of computing literacy:
familiar with Microsoft Office (National Training Register exam #4713139139003), Empower 2, OpenLab, MSD
Security Chemstation, Chromeleon, SAP-based systems (Glorya, GuideReg), LIMS, etc.
Handles challenging and stressful situations with integrity, initiative and logic
PUBLICATIONS, PRESENTATION, POSTERS:
“Development of a GC method for the determination of methylacrylate in liophylized products (1 mg, 2 mg and 5 mg strength)”,
ANOLI prize – Scientist category; Reward for the topic selection, Hungarian Society for Pharmaceutical Sciences, April 9-
11 2015, Balatonfüred, Hungary
Gas Chromatographic Mass Spectrometric Analysis and Subsequent Quality Improvement of Plastic Infusion Packaging
Materials, J. Pharm. Biomed. Anal., Vol. 97, 25 August 2014, Pages 111–115
“Investigation of Opalescence Phenomenon on Polymer Packaging Materials of a Large Volume Parenteral Drug Applying
Temperature Modulated DSC, SEM, GC-MS and XRD – Case Study”; Z. Fekete, T. Rófusz, V. Angyal, P. Szabó-Révész, Z.
Aigner, Poster presented at the 2nd Central and Eastern European Conference on Thermal Analysis and Calorimetry,
August 27-30, 2013 Vilnius, Lithuania
“Optimization of Composition of Infusion Packaging Materials in Sterile Pharmaceutical Development”; Zoltán Fekete, Tímea
Rófusz, Presentation held at the Hungarian Academy of Sciences Dept. of Thermal Analysis, May 16, 2013
“Quality improvement of infusion packaging materials exemplified by {a case study}”, Tímea Rófusz, Zoltán Fekete - 1st prize
in the national TEVA “Young Professionals” competition from all three Hungarian TEVA sites; finalist in the
international competition from all TEVA sites
2. CURRICULUM VITAE
Tímea Rófusz, Phone: +36-20/552-0516, E-mail: rofusz.timea@gmail.com 2/2
PROFESSIONAL EXPERIENCE:
Analytical Expert:
TEVA Pharmaceutical Works Plc, Quality Control Department (October 2012 - 31 March 2016)
HPLC/UPLC, IC, GC/GC-MS analysis of APIs and sterile dosage forms
Method development ("Anoli prize" competition; see publications), validation, verification, transfer and routine
analysis
Responsible person for equipment qualification and its respective documentation and for maintenance of the HPLC column
database; excel template validation
Responsible person for standards and reference materials
Contribution to the investigations of customer complaints, OOS results, deviations (Investigation of interference in a cleaning
validation method; see achievements. This investigation was the basic for my thesis to my post graduate diploma; see studies.)
Analytical Expert:
TEVA Pharmaceutical Works Plc, Generic Research & Development Department (November 2010 - September 2012)
GC/GC-MS analysis of APIs and sterile dosage forms (TEVA "Young professionals" competition; see publications)
Method development, validation, verification, transfer and routine analysis.
Contribution to the investigations of OOT/OOS results, deviations, CAPA processes
Contribution in the establishment and installation of a new, GMP-compliant GC laboratory
Issuing project documentation, e.g. method descriptions, method validation protocols/reports, expert reports, SOPs.
R&D Analyst:
Gedeon Richter Plc., Analytical Research Department (February 2008 - October 2010)
Method development, validation, verification, transfer and routine analysis of residual solvents and
volatile degradation products in drug substances by GC.
Characterization and determination of unknown impurities by GC-MS.
Compilation of core project documentation, e.g. method descriptions, method validation protocols/reports, laboratory reports
Head of Laboratory:
Medinspect Ltd. (February 2006 - January 2008)
Laboratory installation: establishment of the quality system (SOP's, Quality Operal Manual, method
descriptions) and preparation for the Health Authority inspection.
Analytical method development for the determination of drugs of abuse from biological samples (urine, blood and saliva) by
HPLC and GC-MS.
STUDIES:
Diploma in Instrumental Analytical Chemistry, M.Sc. (Budapest University of Technology and Economics, 2014) — #PTF036554 Identification for
Institution: FI23344 Number: 8225; Grade: excellent
- Main subjects: Mass spectroscopy, Bioanalysis, Electroanalysis, Chromatographic techniques, Chemometrics
Diploma in Bioengineering, M.Sc. (Budapest University of Technology and Economics, 2004.) – #PTF 005689, 165/2004; Grade: good
High School Diploma (Géza Gárdonyi Cistercian High School, 1998.)
OTHERS:
Medium level English speaker (B2) and Basic level German speaker (A2).
multinational work experience
willingness to relocate
From outdoor activities, I love to explore the nature. I especially adore mushroom hunting, as this brings back childhood
memories.
In my spare time, it is writing what I enjoy the most. My first fantasy novel titled ‘White flames fluttering’ was published in 2013.