Job Title: On-site QA Scientist
Reporting To: QA Supervisor
Main Responsibilities:
• Conduct on-site inspections of production workshops and warehouses to ensure compliance with GMP and relevant quality standards
• Review and approve the release of raw materials, ensuring they meet quality requirements before use
• Review and approve the release of packaging materials, ensuring compliance with specifications
• Manage and issue cleaning records, ensuring traceability of the cleaning process
• Review master cleaning records to ensure compliance and effectiveness of cleaning procedures
• Handle cleaning deviations, coordinate with relevant departments for investigation and implementation of corrective actions
• Review cleaning impact assessments to evaluate the potential impact of cleaning deviations on product quality
• Participate in continuous improvement of the quality management system and promote on-site quality management
• Maintain effective communication with production, warehouse, and quality-related departments to ensure smooth information flow
Qualifications:
• Bachelor’s degree or above, preferably in Pharmacy, Chemistry, Quality Management, or related fields
• 1-3 years of experience in QA or production in the pharmaceutical industry,familiar with GMP and related regulatory requirements
• Proficient in on-site quality management processes; capable of working communication in both Chinese and English
• Strong communication and coordination skills with a team-oriented mindset
• Detail-oriented, responsible, with strong problem-solving and analytical abilities