Dr. Monika Maroda, PhD

Telephone: +36306369898

Profile

MSc qualified (from Chemistry and Physics) and PhD qualified from Pharmaceutical science with 15+ years’ experience Pharma industry. Team leader of multidisciplinary project teams to deliver technical projects, team structure typically consists of representative from the following functions: quality, production, engineering, logistics and finance.Project plan owner and developer keeps accountable for ensuring that key project milestones are achieved and escalate any potential resource conflicts, capacity issues, supply / demand issues or technical difficulties. Validation/quality/RA specialist and developer knowledge guarantee the qualified work with the project team and appropriate facilitators to ensure robust, fit for purpose processes and products are delivered and that key learning’s are captured as part of knowledge management. BI system developer improves the transparency and efficiency.

Key Competencies

Product development and implementation
Process development and scale up
Formulation development
Project management, Samlingqualified, MBA student
Ability to manage and steer teams
Building external and internal networks
Production troubleshooting and problem solving
Ability to work in inter- and multidisciplinary environment / Laboratory capability management
G.M.P, G.L.P, ISO9001 and ISO22716
Environmental, Health and Safety standards, RAMS
QMS and GMP Auditing for continualimprovement
Method Development/Validation/Optimisation
HACCP management
RA management
Lean management

Career History and Key Achievements

Senior Project Manager Jan 2015 – to Jun 2015
AMCo (formerly Amdipharm Mercury Ltd) London, United Kingdom
  • Strategic planning, initiation the projects, leading, global overview, monitoring of the execution and reporting to high level management. The role requires leadership and ability to coordinate between different local functions and stakeholders such as marketing, patents, R&D, QA/QC, RA, TSA, production units, etc. I worked in very tight connection with US, EU and International RA, Supply Chain and Portfolio units.
Site Project/ Global Manager Jan2011– to Jan 2015
TEVA Pharmaceutical Works, Hungary
  • I have performed several transfer between two sites: from Teva Sante /France site, Teva Ivax from Ireland, from Teva Italy, APS/Berk as Teva Teva UK, Teva Gödöllő, Teva Israel, Canada and India To Hungary.
  • Teva Sante / France site, Teva Ivax /Ireland, Teva Italy, APS/Berk as Teva Teva UK, Teva Gödöllő site were global projects where I performed the fully or partly site closure as well.
  • I have leaded the Harmonization projects between all of EU sites (portfolio optimization).
  • Accountable for the management, control and budget for the implementation of NPD and change projects at TEVA, including formulation validation and stability program management, raw material selection, method of manufacture, quality and cleaning procedures through to filling and final handover to Operations.
  • Leading various types of projects; namely sourcing, site, material and process improvement projects(key diamond projects).
  • Global manager for execution of the EU harmonization between 2013/2015.
  • Accountable, as the site technical specialist for supporting in sourcing and out sourcing projects across all areas working closely with third party manufacturing organisations and the material suppliers.
Main achievements
  • Successfully launched over 140 new products / 70+ formulations
  • Enabled change of a key raw material supplier to achieve a 30% reduction in material cost
  • Several NPIS template development in the BI system.
  • Best scorecard as TEVA Project manager in 2013.
  • 2000SKUswere switched in the two years with transfer and harmonization projects.
  • Good achievement in harmonization projects- (25 key molecule) 50+ colleagues reported me
  • Completed transfer of 70 new products from another plant; re-developed methods of manufacture to adapt to the site capabilities.
  • annual saving :1projec:4.5 M USD /10 projects:3M-1M USD /25+projects: 30projects / rest:1M-100th USD
.

Earlier Career Highlights

Promoted from TevaDevelopment engineer- Pharma Technologist- Validation team leader

2002-2011

  • Managed of technical transfer and scale-up for new products and processes to production scale
  • Provided of technical support service to the Marketing teams as part of NPD process
  • Managed the manufacturing methods and maintained the necessary quality documentation.
  • Troubleshooted and fixed production issues, related to bulk formulations and raw materials.
  • Liaised with Formulation, Production, Purchasing and Marketing teams to ensure successful new product launch on time.

ACHIEVEMENTS

  • Managed 200 technical transfer projects across a 9 year
  • Received an award TEVA Young Technician/Technology Competition in 2006
  • Modernized the old manufacturing procedure and polishing up the European registration documentation
  • Achieved 25 cost saving due to process improvement and batch size optimization

2000 – 2002 TEVA, Validation Supervisor- Documenting colleagues

  • Supervised the validation, checked and wrote the validation SOPs and checked the activities and documentation regarding cleaning validation, equipment qualification (IQ, OQ, PQ) process validation and analytical validation
  • Development of regulating instructions in connection with the validation activities
  • Management of the cleanliness validation team
  • Giving opinion on the documents from the quality assurance point of view.
  • Development of the system for checked modifications, and establishment of computerised document records.

1998 – 2000 ICN, Measurement and plant laboratory manager

  • Supervision of twelve laboratory assistants
  • Organisation of the execution and documentation of laboratory tests in connection with the manufacture of products.
  • Development and implementation of new chemical analysis methods
  • Organisation and supervision of the production (co-ordination of shifts in a three shift /working system)

Key Training

ISO 22716 GMP and ISO 9001 Internal Auditing
ISO 9001 Foundation for Implementation
Hazard Analysis of Critical Control Points (HACCP)
Examination of project management (Samling-14548/11)
Examination in first aid application at work, Hungarian Red /Cross examination board / Examination in 'The principles of good medicine production GMP’, Semmelweis University, Medicinal Science Faculty
Examination in computer operator, user training course (Nat. Reg. No. OKJ334641).
ECDL examinations

Education

2013 Doctoral Degree in Pharmaceutical science, University of Szeged

1992-1997 Master’s degree in Chemistry and Physics, Lajos Kossuth University of Debrecen

2015Anglia Ruskin University student MBA -(Project Management) by distance learning

(LBE for termination 2017)/ Cambridge campus

Key I.T Skills

  • MS Office Suite (Word, Excel, PowerPoint) and Internet Explorer
  • UK driving licence

Languages: / Native: Hungarian speaker, English: Fluent, Russian basic
Interests: / Running, cooking, keeping fit.

References available on request