QP coordinator

Thermo Fisher Scientific

  • Bleiswijk, Zuid-Holland
  • Vast
  • Voltijds
  • 1 dag geleden
Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeJob DescriptionPosition Summary:To support the QP function within Fisher BioServices to achieve department goals, including collation of documents for QP certification, generation of QP certificates and generation of QP declarations.Key Responsibilities:
  • Coordination and internal communication regarding the scheduling and completion of the documentation review and approvals.
  • Supply of information internally regarding documentation review and approval process to support project planning
  • Collation of documents for QP certification for all product types including ATMPs
  • Generation of QP certificates as instructed.
  • Generation of QP declarations as instructed.
  • Documenting and Monitoring QP training
  • To act as QP designee with completion of ‘Non QP’ releases as instructed.
  • Maintain QP SOPs as requested
  • Liaise with QP customers on routine issues.
  • Work with QPs to improve team processes.
  • Performs required duties as an approved Archivist
  • Maintain QP Batch Registers
  • Maintain Clinical Trial files and Product Specification Files for all product types including ATMPs
  • Generation of Metrics as the need arises and support to improve quality metrics
  • Inputting or analyzing data for quality metrics
  • Inform Supervisor of quality issues
Minimum Requirements/Qualifications:
  • Bachelors degree in science or significant experience in a GxP environment
  • Experience in review of documentation
  • Ability to work independently but also in a team
  • Experience within a Quality environment.
Non-Negotiable Hiring Criteria:
  • Experience in the pharmaceutical industry in a manufacturing, analytical or quality position
  • Good oral/written communication skills in English
  • Skills in detailed work
  • Experience in project work, including continuous improvement processes.

Thermo Fisher Scientific