Regulatory & Quality Executive
- Singapore
- Permanent
- Full-time
- Maintain and continuously improve the effectiveness and efficiency of the Quality systems, processes and procedures.
- Enforce compliance with internal procedures to ensure that established quality and process procedures are being followed by personnel at all times.
- Quality oversight/assist on Environmental Monitoring Systems and calibration & preventive maintenance processes of the company.
- Manage the processes of change control and change notification.
- Quality oversight/assist in the validation and qualification projects and processes of the Company.
- Quality oversight/assist in supplier / contractor management (complaints follow up, supplier audits etc.)
- Assist the Main Document Controller of the company, who updates, issue and retrieve quality management system documentation.
- Assist the archival process of quality management system documentation.
- Manage/Assist the application and renewal of permit and licenses required by the Company.
- Manage the processes of Customer Complaints, Material Disposition and Product Recall.
- Management of quality non-conformity e.g. Unplanned Events, Corrective and Preventive Action (CAPA) etc.
- Coordinate, evaluate, and assist in developing action plans and follow up of quality issues.
- Lead/assist in external audit from customers and regulatory agencies and follow-up on audit closing.
- Lead/assist internal audits and ensure timely closure of audit findings (if any).
- Assist batch release of materials (Bin quarantine, release or reject, COA/COC verification)
- Other duties as assigned.
- Diploma, Degree or equivalent
- At least 3 to 5 years of working experience in quality assurance.
- Proficiency in Microsoft office and SAP.