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Quality Assurance Specialist
vor 2 Monaten
We are seeking a highly skilled Quality Assurance Specialist to join our team at Thermo Fisher Scientific.
Key Responsibilities:
- Review and quality approve pre-executed batch documentation and finished product with TOE and label components.
- Support QA Pre-Approval by reviewing and approving batch records, change orders, packaging and labelling requests, job specifications, and LINKS reports.
- Liaise with project managers to ensure documentation meets customer and regulatory requirements, including GCP and GMP guidelines, and Fisher Clinical Services Standard Operating Procedures (SOPs).
- Coordinate and communicate internal 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 analyse 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.
- Organise and execute GMP document archival (internal/external).
- Participate in Practical Process Improvement or other projects.
- Review and disposition decisions according to the agreed customer process for transport deviations and temperature excursions.
- Support the review and approval of Pharma Unit Trackwise problem reports (PRs).
- Act as a customer quality contact, answering client questions with regards to executed batch records.
