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