Quality Assurance Specialist

About the role

The Quality Assurance Specialist will support the maintenance and continuous improvement of QA procedures, ensuring compliance with global DKSH quality policy and local regulatory standards. This role involves close collaboration with production, training, and compliance teams to uphold GMP, GDP, and QMS requirements.

Key responsibilities

• Support maintenance of QA procedures, processes and standards.
• Assist in developing SOPs, quality checklists, and supporting tools in line with GMP/GDP/QMS.
• Handle complaints, deviations, training records and change control activities.
• Assist in qualification and validation of equipment and facilities.
• Perform data analysis to identify operational improvements.
• Maintain controlled document files and quality records accurately.
• Provide training on SOPs, GMP/GDP, ISO standards and offer technical assistance to production.
• Conduct inspections/self‑inspections of warehouse operations for compliance.
• Inspect incoming shipments and returned products.
• Execute other ad‑hoc QA tasks as assigned by management.

Required profile

• Degree or diploma in a science‑related field.
• Experience in the pharmaceutical industry is preferred.
• Strong communication skills in English and Chinese.
• Proficiency with MS Office applications and SAP.
• Certificate in quality management systems is a plus.
• Familiarity with ISO 9001, ISO 13485, GDP and PIC/S GMP practices is preferred.

Required skills

• MS Office
• SAP
• ISO 9001
• ISO 13485
• GDP
• PIC/S GMP