百济神州｜理化分析师(物料） Physical Analyst (Material)

- Responsible for the testing and release of raw materials and packaging materials. - Participate in new product/project implementation activities related to materials and packaging components, including but not limited to gap analysis, risk assessments, method validation, equipment qualification, document preparation and approval, material testing, and release activities. - Participate in the design, setup, qualification, and commissioning of new laboratories, including laboratory equipment and furniture. - Participate in equipment qualification, method validation, method development, and method improvement activities as required. - Support process validation, cleaning validation, and laboratory deviation investigations. - Keep abreast of applicable regulations and industry requirements; draft, review, and update laboratory procedures, specifications, work instructions (WIs), forms, records, and other quality documents to ensure compliance with regulatory requirements. - Responsible for the investigation of OOS (Out-of-Specification) and OOT (Out-of-Trend) results and the timely completion of investigation reports. - Responsible for coordinating instrument calibration, qualification, and routine maintenance activities to ensure equipment remains in a qualified state. - Comply with company EHS policies and procedures, fulfill EHS-related responsibilities, and promptly report EHS incidents, hazards, and risks.

- Bachelor's degree or above in Pharmacy, Biology, Chemistry, Pharmaceutical 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.