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কাজের বিবরণ
About the Role
Our company is looking for a dedicated Quality Assurance Specialist to enhance quality management in a GMP-regulated manufacturing setting. This position plays a critical role in overseeing production quality for assembly, labeling, packaging, and other manufacturing operations to ensure compliance with GMP, ISO 13485 standards, and internal quality guidelines.
Key Responsibilities
- Conduct in-process inspections and ensure line clearances are properly performed.
- Verify equipment functionality and adherence to standards throughout manufacturing processes.
- Implement AQL sampling techniques to assess the quality of finished products.
- Maintain precise Device History Records (DHRs) documenting production activities.
- Investigate and resolve quality issues, supporting root cause analyses.
- Collaborate closely with manufacturing teams to maintain product quality standards.
- Assist with the organization and management of quality documentation.
- Help train new quality control personnel and maintain comprehensive quality records.
Qualifications and Experience
- Minimum of three years’ experience in Quality Control or Quality Assurance roles within medical device, diagnostics, or pharmaceutical manufacturing environments.
- Well-versed in ISO 13485, Good Manufacturing Practices (GMP), and FDA quality systems.
- Strong skills in quality documentation and record keeping.