Job Description - Responsible for conducting gap analyses and drafting risk assessments related to microbiological and sterility assurance activities. - Responsible for sterility assurance assessments and continuous improvement of manufacturing processes, including the establishment and maintenance of the Contamination Control Strategy (CCS). - Perform microbiological data trending and analysis to identify risks and improvement opportunities. - Responsible for microbiology-related change control assessments and approvals. - Draft, revise, and maintain procedures and other GMP-related documents. - Responsible for investigation of AE, MDD, and deviations, and ensuring timely closure of investigations and associated actions. Initiate change controls and ensure their effective and timely implementation and closure. - Organize and deliver technical training related to microbiology and sterility assurance. - Responsible for the maintenance, qualification, and management of laboratory equipment. - Comply with company EHS policies and procedures, fulfill EHS-related responsibilities, and promptly report EHS incidents, hazards, and risks. Qualifications & Competencies - Bachelor's degree or above in Microbiology, Pharmacy, Biotechnology, Life Sciences, or a related discipline. - Good command of English and computer skills; CET-4 (College English Test Band 4) or above. - Positive, responsible, and willing to learn and take initiative. - Good teamwork, organizational, analytical, and problem-solving skills. - Good communication and interpersonal skills.