• Assist QA Department's daily operations.
• Prepare cleanroom / utilities / equipment DQ/IQ/OQ/PQ protocols and reports, and various validation Protocols and reports.
• Prepare initial assessment of Product Quality Review and Management Review Reports and submit to Authorized Person and management.
• Prepare SOPs related to QA Department.
• Plan and provide practical and compliant solutions in change controls, deviation investigations, OOS investigation, CAPA, quality risk assessments, qualification and validation, supplier evaluations, and continual improvement.
• Raise quality issues to the Authorized Person and management in a timely manner.
• Work with the Authorized Person to develop and monitor quality KPI.
• Other duties as assigned by Authorized Person and/or management team.
  
  
  

• Bachelor's degree or above in biotechnology, biochemistry, chemistry and medical laboratory science or science degree with relevant to cell therapy, gene therapy, regenerative medicines or tissue engineering, or other similar sciences disciplines;
• 2 years of experience in quality assurance role in pharmaceutical GMP environment is preferred
• Knowledge of PIC/S GMP and other quality system / quality assurance principles is highly preferred.
• Received formal training on Quality Management System e.g. ISO 9001 Internal Auditor is highly preferred.
• With knowledge and/or experience in GMP operations of sterile pharmaceutical products, biological substances or products, or cell-based products is highly preferred.
• Excellent communication, problem-solving, time management and prioritization skills.
• Self-motivated and a good team player, attention to details.
• Proficiency in English and Chinese.

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