百济神州
理化分析师(物料) Physical Analyst (Material)
岗位职责
- 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
任职要求
, 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. Qualifications & Competencies - 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.
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