Quality Assurance Specialist

vor 4 Wochen


Allschwil, Basel-Land, Schweiz Thermo Fisher Scientific Vollzeit
Job Title: QA Specialist

At Thermo Fisher Scientific, we are seeking a highly skilled QA Specialist to join our team. As a QA Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities:
  • Review and approve batch records, certificates of packaging, and other documentation to ensure compliance with regulatory requirements.
  • Support the QA Pre-Approval process by reviewing and approving pre-executed batch documentation, finished products, and other related documents.
  • Liaise with project managers to ensure that all documentation meets customer and regulatory requirements, including GCP and GMP guidelines.
  • Coordinate and communicate with internal teams regarding documentation reviews and approvals.
  • Provide support to improve documentation right-first-time metrics and ensure that any deviations or quality issues are properly documented.
  • Input and analyze data for quality metrics and inform supervisors of any quality issues.
  • Maintain accurate records for all work activities and provide training and introduction for new team members and other departments.
  • Organize and execute GMP document archival and provide support to the larger Quality department as needed.
Requirements:
  • Experience or degree in the pharmaceutical industry, quality control/quality assurance, medication handling, or a scientific field.
  • GxP training or experience.
  • Demonstrated ability to perform detail-oriented tasks.
  • 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 a professional level.


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