Zuzana Mellenova

Project Manager at Smithers - Medical Device Testing
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Contact Information
us****@****om
(386) 825-5501
Location
United Kingdom, UK
Languages
  • Slovak -
  • Polish -
  • English -

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Project Manager
      • Jun 2022 - Present

      Project Manager Smithers - Medical Project management and technical leadership for analytical testing service in pharmaceutical and medical industry. Preparing analytical study plans including critical path, budget, work structure and work packages. Collaborating with subject matter experts to define the scope and technical solutions. Executing studies by managing laboratory operations, risks, budget, scope, project milestones and communications with internal and external stakeholders. Generating quotes for new work programmes, including cost and time estimates. Reviewing and reporting analytical data from a wide range of analytical techniques (chromatography and mass spectra, FTIR, ICP, UV, conductivity, pH). Ensuring adherence to client requirements, legislation and quality standards (cGMP). Show less

    • United Kingdom
    • Dairy Product Manufacturing
    • 1 - 100 Employee
    • Laboratory Manager
      • Jan 2013 - Jun 2022

      Oversee the day-to-day operations of both the laboratory and sample receipt ensuring all samples are processed and analysed within the acceptable time limit and to the highest standards of quality.Report any issues or developments to the Head of Laboratory OperationsMonitor the day-to-day delivery of the analysis, to maintain and/or improve qualityStaff management – H&S, HR Financial management of the laboratory i.e. spend on consumables etc.Spend sufficient time in the laboratory to maintain suitable technical and procedural knowledge, in order to effectively fulfill the responsibilities of the role.Ensure all communication surrounding laboratory results is sent to the correct people within an agreed timescale and in a professional formatKeep up to date with the relevant legislation, customer requirements Active involvement in Internal and External audits and customer visits.Ensure appropriate levels of resources are available for the projected workloadEnsure that all staff receive appropriate training and develop skill setsRecruit, interview, and select staff that have the right technical and personal abilities to help further in the laboratories developmentSupport and maintain the Quality Management SystemBe involved in the creation, review, and amendments of all documents where required.Ensure tests and procedures are properly documented, understood, carried out, and evaluated.Support Quality Management in terms of technical validation and supporting documentation. Show less

    • Section Head
      • Sep 2012 - Dec 2012

    • Section Head
      • Oct 2011 - Aug 2012

    • Laboratory Analyst
      • Aug 2006 - Nov 2011

      Perform work as allocated by Team Leader to the high standards of quality required within the 24 hour turnaround time and inform the Team Leader/Laboratory Manager in cases of doubtful validity of results or un-testable samples.Inform Team Leader / Senior Lab Analyst of any problems encountered in analysis, including possible malfunctioning of equipment.Inform Team Leader / Senior Lab Analyst in advance if agreed deadlines for work completion are unlikely to be met.Inform the Team leader / Senior Lab Analyst when additional stocks of chemicals and consumables need to be placed on order.Ensure completion of all necessary documentation/records – temperature monitoring, combi start-up and shutdown, pilot definition sheets, etc. Ensure that all samples are scanned in and webbed correctly, and checked for test requests.Ensure samples have been transferred to the appropriate section of the cold store after testing and that crushing, washing, and reassembly of the boxes are undertaken on daily basis.Ensure that all laboratory areas are clean and clutter-free at all times Show less

Education

  • Gymnazium Nove Zamky
    1997 - 2005

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