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Quality Assurance Specialist
vor 2 Monaten
We are seeking a highly motivated Quality Assurance Specialist to join our team at Thermo Fisher Scientific.
Key Responsibilities:- Review of Executed Batch Records: Ensure accurate and timely review of batch records to ensure compliance with regulatory requirements.
- Support QA Pre-Approval: Provide quality approval for 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.
- Liaison with Project Managers: Collaborate with project managers to ensure documents meet customer and regulatory requirements, including GCP and GMP guidelines, and Fisher Clinical Services Standard Operating Procedures (SOPs).
- Cordination and Internal Communication: Coordinate and communicate the scheduling and completion of documentation reviews and approvals internally.
- Supply of Information: Provide internal information regarding the documentation review and approval process to support project planning.
- Quality Metrics: Analyze data for quality metrics and provide input for improvement.
- Deviations and Quality Issues: Document deviations or quality issues appropriately and inform supervisors.
- Experience in Pharmaceutical Industry: Bachelor's degree in science or equivalent, experience in quality control/quality assurance, medication handling, scientific field, or equivalent.
- GxP Training: Demonstrated ability to perform detail-oriented tasks and high level of accuracy and efficiency.
- Language Skills: Command of English and German at professional level.
$70,000 - $90,000 per annum based on location and experience.
