The Head of Quality Assurance will play a pivotal role in ensuring that our pharmaceutical and medical devices meet or exceed regulatory standards, industry best practices, and customer expectations. The successful candidate will be responsible for developing, implementing, and overseeing the quality assurance processes and systems to uphold the highest product quality and compliance standards. Key Responsibilities: Quality Management Systems (QMS): Develop, implement, and maintain a robust Quality Management System (QMS) in accordance with relevant regulations and standards. Conduct regular assessments to ensure the effectiveness and continuous improvement of the QMS. Regulatory Compliance: Stay abreast of international pharmaceutical & device regulations and standards, ensuring the company's compliance with regulatory requirements. Collaborate with regulatory affairs teams to obtain and maintain product registrations and certifications. Quality Control: Establish and oversee quality control processes for incoming goods. Implement auditing protocols to ensure the quality and consistency of pharmaceutical and medical devices. Supplier/Vendors Quality Management: Develop and maintain strong relationships with suppliers & vendors, conducting regular audits and assessments to ensure supplier/vendors compliance with quality standards. Collaborate with procurement teams to qualify and monitor suppliers/vendors. Continuous Improvement: Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize processes. Lead investigations and corrective/preventive action plans in response to quality issues. Key Performance Indicators (KPIs): Establish and monitor KPIs related to product quality, compliance, and operational efficiency. Regularly report on KPI performance and implement corrective actions as needed. Training and Development: Provide leadership and guidance to the Quality Assurance team. Develop and deliver training programs to enhance the skills and knowledge of QA staff and other related staffs.
Key Area Ensure 90% of shipments are cleared in a timely manner in order not to pay damages and detention charges Ensure all customers duty, commercial taxes, and other taxes are to be levied and correct Apply and obtain required import license in a timely manner Track and collect all pertaining documents before the arrival of the cargo Disseminating all pertaining shipment documents to the accounting department that is necessary for SAP processing before the clearance of the cargo Update 100% of tax exemption status and update the changes of other laws, rules & regulations Inform shipper and international procurement managers and concerned parties in a timely manner for the incidents of damage and quality claimants and ensure the company gets back the claimed amount. Other Area Manage the Import/Export process and ensure compliance with local laws and foreign government laws and regulations Expedite the flow of traffic to/from foreign destinations, including customs documentation and transportations Oversee the completion of parperwork and monetary transactions associated with distribution in atimely manner Negotiate with clients and handle issues with customs officials Consultation to the principals and suppliers regarding insurances, duties and taxes Liaise with principals and suppliers to resolve any shipment related documentation discrepancies to ensure a smooth clearance process Ensure the efficiency and effectiveness of imports and exports processes Control any delay that may occur during the export and import process Apply for required import license on time Perform shipment clearance on time Plan and prepare for adequate foreign currency reserve to make the supplier payments Process the payments to overseas suppliers on time Process tax refund and deposit refund from the government in a timely manner Ensure minimizing unnecessary expenses Prepare and provide accurate management reporting periodically in a timenly manner Follow the rules and regulations and maintain the requirements of the Quality Management System in accordance with ISO guidelines Ensure the current working procedures are in compliance with specified SOPs Train and supervise the staff to get knowledge of specified SOPs and process in order to comply with its requirements Ensure department related documents are archived in accordance with the corporate document retention policy Perform any other tasks as assigned by the management