Quality Assurance Specialist
Vor 6 Tagen
Role: QA Specialist
Department: Quality Assurance
Location: [Company Location]
Job Type: Full-time
Key Responsibilities- Review and approve executed batch records to ensure compliance with Good Manufacturing Practice (GMP) guidelines.
- Support the QA Pre-Approval process by reviewing and approving pre-executed batch documentation, finished product with TOE and label components, change orders, and packaging and labelling requests.
- Liaise with project managers to ensure that all documentation meets customer and regulatory requirements, including GCP and GMP guidelines, and Fisher Clinical Services Standard Operating Procedures (SOPs).
- Coordinate and communicate with internal teams regarding the scheduling and completion of documentation reviews and approvals.
- Provide information and support to project planning teams regarding the documentation review and approval process.
- Contribute to improving documentation right first time metrics.
- Document and report any deviations or quality issues.
- Analyze data for quality metrics and provide insights to the team.
- Inform the Supervisor of any quality issues.
- Maintain accurate records for all work activities.
- Train and introduce new team members and other FCS departments on quality procedures.
- Organize, execute, and document GMP document archival (internal and external).
- Support the larger Quality department by participating in projects, reviewing and approving transport deviations and temperature excursions, and supporting the review and approval of Pharma Unit Trackwise problem reports.
- Experience or degree in the pharmaceutical industry, quality control/quality assurance, medication handling, or a scientific field.
- GxP training or experience.
- 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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