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    Quality on the Floor - Groningen, Nederland - Thermo Fisher Scientific

    Thermo Fisher Scientific
    Thermo Fisher Scientific Groningen, Nederland

    6 dagen geleden

    Thermo Fisher Scientific background
    Voltijd
    Beschrijving

    To assure compliance, quality systems are defined, implemented and maintained. The Quality Affairs Department is responsible for development, implementation, updating, auditing of and reporting on the status of the Quality Systems of Thermo Fisher Scientific Groningen and operational Quality Assurance, Quality Control tasks in relation to the manufacturing operations and batch disposition decisions.

    The Quality Officer on the floor serve to ensure that cGMP manufacturing activities are completed in accordance with cGMP requirements ( good documentation practices), adhere to the approved Standard Operating Procedures, are consistent with emerging/existing corporate & regulatory guidelines as necessary and are continuously improved through demonstrating the Quality Systems architecture and execution by the organization.

    The Job

    The job of Quality Officer on the floor will include a selection of the responsibilities mentioned below:

  • Quality on the floor: direct engagement, real time, of Quality professionals with manufacturing shop floor operations including cGMP guidance, document review and approval, deviation handling and advice regarding documentation quality practices. Significant shift work may be required.
  • Practical application of various risk assessment tools ( failure mode effect analysis, fishbone diagrams, hazard and operability studies) and the ability to directly develop, participate and advise others on the appropriate and efficient application of these processes.
  • Advise, facilitate, and support all phases of manufacturing batch documentation development including, but not limited to the initiation, authoring, approval and mastering.
  • Quality review and approval of cGMP documentation.
  • Alignment of Standard Operating Procedures, documentation practices, laboratory testing, and efficient documentation flows in the Quality release of raw materials, buffers/media and area/equipment.
  • Use, scope, development and orchestration of incident investigations toward the goals of both adequately understanding root cause (including causality vs correlation) and avoiding repeated incidence (corrective action, preventative action and effectiveness verification). Handling of deviations.
  • Application of cGMP change control.
  • Work with complex and comprehensive electronic databases ( Trackwise) to document events related to product quality.
  • Support regulatory inspections from readiness exercises through direct agency engagements.
  • Operate in a variety of modes as it pertains to risk adjusted Quality oversight models driven by the mode of manufacturing being employed.
  • Effectively communicate in multiple modalities ( electronic, written, verbal, etc.).
  • Execution of internal audits.

    • You have/ are

  • HBO level in a relevant field (Biochemistry, Microbiology, Biotechnology, pharmacology) or equivalent.
  • Proficient in English
  • Minimum of 5 years relevant experience in a (bio) pharmaceutical company.
  • Excellent knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines.
  • Experience with project management.
  • Good interpersonal skills.

    • Competences

  • Flexibility
  • Communication
  • Problem analysis
  • Initiative
  • Judgement
  • Independent
  • Result oriented.
  • Persuasiveness
  • Planning & organization

    • Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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