At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Position Brand Description: Concisely summarize the primary purpose & key accountabilities of the position.
To ensure that laboratory control procedures comply with GMP and Corporate policies.
To confirm the quality system with Microbiological test in microbiology Lab, preparation of SOPs, Training program. To qualify the test method related to Microbiological/sterility test, method transfer, method verification/validation will be completed on time. And support the equipment qualification relating to test/Sterility test.
Key Objectives/Deliverables: In order of importance, describe the primary responsibilities, which must be completed to achieve the objects of the position. The description should cover approximately 90% or more of the job content.
Responsible for microbiological analysis for Utility System, e.g., bio burden test, bacterial endotoxin test.
Responsible for analysis for system cleaning validation, e.g., bioburden test, bacterial endotoxin test, liquid particulate matter and protein residual.
Responsible for identification for microorganisms.
To take responsibility for other Microbiological analysis in microbiological lab and it should be complied with both Chinese GMP and Lilly GQS600s requirement.
To Maintain material in micro lab complying
- 负责分析调查（Analytical Investigation and Observation）（可选）
Responsible for analytical Investigation (Analytical Investigation and Observation) complying with GQS604
Micro Lab continuous improvement.
- 负责微生物部分的数据真实有效性评估 （可选）
Responsible for data Integrity in Micro.
- 负责变更的执行 （可选）
In charge of change control happened in laboratory.
- 支持设备验证 （可选）
Support equipment qualification.
- 协调组织GQS 600和相关法规要求的合规性评估 （可选）
Coordinate Gap assessment for GQS 600 and related regulatory requirement.
Delegation from supervisor to approve GMP documents (including Method validation/verification related protocol, Assessment Form for Pharmacopoeia Change etc)
To prepare the analytical reports and other documents in order and organized format.
To support routine operation of microbiology lab
To assume other tasks related to Quality.
To be responsible for drafting and revising the Test Procedures, SOPs and WIs related to duty.
To be responsible for the routine lab reports second person verification.
To assist with lab quality system continuously improvement and GLIMS deployment.
Responsible for fresh analysts’ training.
Basic Requirements: Indicate qualifications that are job related, necessary for the performance of an essential function of this position including education/licenses/certifications, relevant experience, technical and/or other job-related skills (Operational skill, foreign language, computer and etc.).
Bachelor degree or above, majored in pharmaceuticals, biology or related sciences
Capable of speaking, writing and read in English fluently
Additional Preferences: Indicate any skills or qualifications that are desirable or preferred attributes for the position.
- 药厂GMP 背景，QC 部门工作经验
Understanding of Good Manufacturing Practices, with previous experience in Pharmaceutical QC
Strong organization skills and the demonstrated ability to develop a plan and drive the timely execution.
Other Information: Include any work schedule (shift, overtime), travel or environment requirements necessary for the performance of the position.
- 该岗位可能需要周末及节假日上班 （可选）
The position may require to work during weekends and holidays
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-14774.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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