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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
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.

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TimeaRofusz_CV_2016

  • 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.