(高级)专员 - 生产支持/(Sr.) Specialist - Manufacturing
On-siteShanghai, Shanghai, China
Job Summary
Participate in new facility design and construction, including process design, FAT, SAT, IOPQ, and CHT to contribute to project delivery. Support initial logistic process development, draft equipment operation procedures, and implement operation readiness plans. Ensure routine GMP/SHE compliance through facility cleaning, cleanroom garment preparation, and component sterilization. Diagnose and resolve equipment malfunctions with maintenance engineers, handle production deviations, and implement CAPA. Support validation activities and maintain data accuracy for GMP areas using SAP, MES, and Veeva systems. Train new employees and enhance team professional capabilities.
Required Qualifications
- College's Degree (Pharmaceutical / Biological is preferred) and above
- 5 or more years' operation experience in the injection pharmaceutical industry
- MNC Bio-pharma preferred
- Experienced in strategic projects of Aseptic Filling facility including design, commissioning & qualification is preferred
- Strong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry
- Fluent communications skills in English is preferred
- Ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders
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