
Senior Sterile Injectables Quality Assurance Professional
2 weeks ago
Senior Sterile Injectables Quality Assurance Professional
Job DescriptionWe are seeking an experienced Senior Sterile Injectables Quality Assurance professional to join our team. The successful candidate will be responsible for ensuring the quality of our sterile injectable manufacturing processes and aseptic techniques.
- Review and Approval of Manufacturing Records
- Discrepancy Resolution
- In-Process Control Data Review
- Product Label Verification
- APQR Report Compilation and Analysis
- Change Control Proposal Evaluation
- Deviation Trend Tracking
- CAPA Plan Approval
- OOS/OOT Investigation Report Review
- Audit Readiness
- Virtual Inspections and Audits
- Remote Guidance
- Virtual Meetings and Communication
- Knowledge of Sterile Injectable Manufacturing Processes
- Validation Methodologies and Regulatory Guidelines
- Analytical and Problem-Solving Skills
- Communication and Documentation Skills
- Team Management and Task Prioritization
- QMS Tools and Software Proficiency
This is a challenging yet rewarding role that offers the opportunity to work with a dynamic team and contribute to the development of high-quality sterile injectable products.
OthersThe ideal candidate will possess a strong understanding of sterile injectable manufacturing processes and aseptic techniques, as well as excellent analytical and problem-solving skills.
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