QA Specialist
Thermo Fisher Scientific
Location Basel, Switzerland
vor 6 Tg.

Job summary :

The QA Specialist, as a member of the QA Pre-Approval team, is responsible for the quality review and approval of pre-executed batch documentation and supporting documentation according to customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs).

The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH (FCS) is able to provide according to FCS quality standards and timelines.

Responsibilities :

  • Review and quality approval of pre-executed batch documentation, change orders, job specifications, packaging orders, label printing requests, randomizations and supporting documentation
  • Liasing with project managers to ensure the above mentioned documents are according to customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs)
  • Coordination and internal communication regarding the scheduling and completion of the documentation reviews and approvals
  • Supply of information internally regarding the documentation review and approval process to support project planning
  • Provide support to improve documentation right first time metrics
  • Ensuring any deviations or quality issues are appropriately documented
  • Inputting or analysing data for quality metrics
  • Inform Supervisor of quality issues
  • Maintain accurate records for all work activities
  • Training and introduction for new team members and for other FCS departments
  • Participation in Practical Process Improvement or other projects
  • Qualifications :

  • Bachelor’s degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling or scientific roleCommand of English and German at professional level
  • Quality mindset and strong working knowledge of GMP and Good Clinical Practices Quality Systems Regulations and international quality standards
  • Ability to understand various operational processes
  • Demonstrated ability to perform detail-oriented tasks
  • High level of accuracy and efficiency
  • Excellent communication and organizational skills
  • Ability to express detail in simple terminology, both written and verbal
  • We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

    Please contact us to request accommodation.

    Learn More

    Melde diesen Job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Bewerben
    E-Mail
    Klicke auf "Weiter", um unseren Datenschutz-und Nutzungsbestimmungen zuzustimmen . Du kriegst außerdem die besten Jobs als E-Mail-Alert. Los geht's!
    Weiter
    Bewerbungsformular