摘要
Responsibility for microbial testing relate work (contain sterile testing, bioburden testing and EM)
About the Role
Major accountabilities:
Operational
OOx/deviation handling CAPA definition KPI trending Ensure all activities in compliance with cGxP, incl. data integrity Review and approval of analytical data / tests (analytical release) Perform microbiological testing of materials and utilities, environmental and personnel monitoring Provide expert support for site qualification and validation activities Maintain and calibrate equipment incl. plan preparation Support in supplier qualification Trending and analysis of KPI/KQI of environmental monitor data. Support sample planning and sampling execution
HSE
Comply with all HSE guidelines Detect and report potential accident, risks and propose solutions Participate in HSE risk assessments Preparation and participation to internal HSE audits Responsible for participating in initial training and retraining
Key Performance Indicators
Analytical lead times Timely and GMP-compliant analysis and documentation of the results Error rate: Number of OOS (analysis errors) related to the number of analyzes No complaints about official inspections
Ideal Background
Relevant Experience
Professional experience (3-5 years) in the pharmaceutical sector or in the manufacture of active substances in analytical laboratories in a GMP environment or equivalent; Collaborating across boundaries; Functional Breadth; efficient inter and intra-departmental communications.
Education & Qualification
Technical education & 3-5 years relevant experience or University degree in Microbiology, Biochemistry or equivalent + 0-4 years working experience
Languages
Good (oral and written) in English; fluent in local language (oral and written)
Competencies
Collaboration; result-oriented Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy MS Office applications and other standard IT applications supporting Quality activities Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; Knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Business Unit
Innovative Medicines
站点
Haiyan (Zhejiang Province)
Company / Legal Entity
CN27 (FCRS = CN027) Novartis Pharmaceutical Technology Zhejiang Co., Ltd.
Apply to Job
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