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QC Microbiological Senior Specialist

  • Gdańsk, pomorskie
  • Specjalista
  • 2017-04-12

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

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    QC Microbiological Senior Specialist
    Miejsce pracy: Gdańsk, Duchnice

    JOB DESCRIPTION:

    • Preparation and revision of quality procedures/ instructions/ validation documentation and microbiological methods.
    • Validation of microbiological methods and participation in the production processes validations in terms of microbiological quality control
    • Performing research and analysis based on the standards, specifications, pharmacopoeias and the principles of GMP and GLP in order to provide information about the tested product and raw materials
    • Keeping records as per GDP standards
    • Reading and verification of microbiological results and data interpretation. Trend analysis.
    • Initiating quality investigations and participating in CAPA implementation in terms of microbiological quality control
    • Change control processes initiation and cooperation during implementation in terms of microbiological quality control
    • Laboratory equipment supervising
    • Taking and testing samples: environmental/clean room monitoring, water, clean steam, gases, raw materials, in process materials, end products
    • Preparation and filling of documentation connected with documentation of results, procedures, reports
    • Qualification of laboratory equipment, validation and verification for microbial methods

    EXPECTATIONS:

    • Higher directional education in Microbiology, Biotechnology, Chemistry or related
    • Very good knowledge of GMP, GLP & GDP
    • Knowledge of microbial methods: Bioburden (water, product), endotoxin test (water, product), QC of media, Microorganisms identification
    • Experience in participation in internal and external audits
    • Very good knowledge of English language
    • Mobility - willingnes to work in two differnet locations

    WE OFFER:

    • Employment contract  with opportunity to help shape the success of a leading private pharmaceutical company
    • Working in a cutting edge biotech laboratory
    • Great opportunity for professional development and participation in training programs
    • Competitive salary, performance-related bonus and attractive fringe benefits