Title:  Specialist Quality Assurance

General responsibilities

• Support maintenance of quality assurance procedures, processes and standards to ensure alignment to global DKSH quality policy and local regulatory guidelines
• Assist in improving quality assurance systems, including the development of SOPs, quality checklists, supporting tools and techniques according to GMP/ GDP/ QMS and legal requirements
• Support handling complaints, deviations, training records and change control
• Assist in qualification, validation of equipment and facility
• Perform data analysis to identify areas for improvement in operation and processes
• Maintain all controlled document files and quality records in a timely and accurate manner
• Provide training to employees on SOPs, GMP/GDP and ISOs, quality awareness and offer technical assistance to production on quality and process improvements as well as trouble shooting when necessary
• Carry out inspection/ self-inspection on warehouse operations to ensure its GMP/ GDP/ QMS compliance
• Perform quality inspection on incoming shipment & returned products.
• Other ad hoc QA activities as assigned by management

Job requirements

• Degree/Diploma holder in science related courses
• Experience in working with pharmaceutical industry is preferred
• Good communication skills in both English and Chinese
• Proficient in MS Office applications and SAP
• Certificate in quality management system is preferred 
• Knowledge in ISO 9001, ISO 13485, GDP and PIC/S GMP practices, standards is preferred