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
