Job Description
In this role, the QC & QA Manager is responsible for standardizing complaint handling infrastructure, standardizing all SOP related medical device handling and responsible for AATB and Tissue Bank licensing is up to date.
- Draft quality assurance policies and procedures
- Interpret and implement quality assurance standards and procedures
- Evaluate adequacy of quality assurance standards
- Devise sampling procedures and directions for recording and reporting quality data
- Review the implementation and efficiency of quality and inspection systems
- Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
- Document internal audits and other quality assurance activities
- Investigate customer complaints and non-conformance issue
- Collect and compile statistical quality data
- Develop, recommend and monitor corrective and preventive actions
- Prepare reports to communicate outcomes of quality activities
- Identify training needs and organize training interventions to meet quality standards
- Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Monitor risk management activities
- Responsible for document management systems
- To create and maintain a product disposal system in accordance with AATB regulations
- To update and maintain complaint handling guideline with respect to product and adverse event complaints
- To establish a non-clinical sample use request and tracking system (Biologics)