Regulatory & Quality Executive

Job Responsibilities:

• 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, issues and retrieves quality management system documentation.
• Assist the archival process of quality management system documentation.
• Manage/Assist the application and renewal of permits 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 on quality issues.
• Lead/assist in external audits 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.

Job Requirements:

• Diploma, Degree or equivalent.
• At least 3 to 5 years of working experience in quality assurance.
• Proficiency in Microsoft Office.