What are the responsibilities and job description for the Quality Assurance Specialist position at Indotronix Avani Group?
Summary
This position will have a wide range of tasks which may include product complaint investigations, root cause analysis (RCA), manufacturing quality process development, maintenance, trending and reporting, deviation investigation, CAPA management, change management, internal / external auditing, supplier quality management, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.
Principal Responsibilities :
- Perform trending and analysis of customer complaint data
- Drive investigations and manage deviations and NCMRs from initiation to disposition
- Perform and lead RCA’s through cross-functional team involvement
- Support the development and maintenance of manufacturing quality control processes for new and existing production areas
- Support supplier quality management for desk audit and quality agreement creation, execution, and review via direct customer contact
- Maintain process Failure Mode and Effects Analysis for new and existing production areas
- Manage CAPA creation and ensure adequate effectiveness
- Improve existing procedures to align with cGMP and regulatory requirements
- Interpret and properly apply all applicable regulatory requirements
- Improve quality culture through site initiatives
- Review and approval of procedures, protocols, reports, etc… as required.
- Perform internal and external audits of systems and suppliers
- Filing and management of documentation when required
- Supporting other Quality System Functions
Minimum Requirements :
