Quality Assurance Specialist

vor 1 Tag

Allschwil, Basel-Land, Schweiz Thermo Fisher Scientific Vollzeit
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and compliance of our pharmaceutical products and processes.

Key Responsibilities
  • Review and approve batch records, certificates of packaging, and other quality-related documents
  • Support QA Pre-Approval by reviewing and approving pre-executed batch documentation, finished product with TOE and label components, change orders, packaging and labelling requests, job specifications, packaging orders, LINKS reports, randomizations, SPA, and supporting documentation
  • Liaise with project managers to ensure documents are according to customer and regulatory requirements, including GCP and GMP guidelines, and Fisher Clinical Services Standard Operating Procedures (SOPs)
  • Coordinate and communicate internally regarding the scheduling and completion of documentation reviews and approvals
  • Supply information internally regarding the documentation review and approval process to support project planning
  • Provide support to improve documentation right first time metrics
  • Ensure any deviations or quality issues are appropriately documented
  • Input or analyze data for quality metrics
  • Inform Supervisor of quality issues
  • Maintain accurate records for all work activities
  • Train and introduce new team members and for other FCS departments (CS, CSOS, etc.)
  • Organize and execute document archival (internal/external)
  • Support the larger Quality department, which may include tasks such as participation in Practical Process Improvement or other projects, review and disposition decisions according to the agreed customer process for transport deviations and temperature excursions, supporting the review and approval of Pharma Unit Trackwise problem reports (PRs), and acting as a customer quality contact
Requirements
  • Experience or degree in the pharmaceutical industry, quality control/quality assurance, medication handling, scientific field, or equivalent
  • GxP training or experience
  • Demonstrated ability to perform detail-oriented tasks
  • Bachelor's degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling, or scientific role
  • Excellent communication and organizational skills
  • High level of accuracy and efficiency
  • Ability to express detail in simple terminology, both written and verbal
  • Command of English and German at professional level

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