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.
Provide support on establishment of environmental monitoring system and routine operations.
Participate in solving of problems that may impact environmental monitoring and utility system monitoring; provide solutions, opinions and suggestions from EM aspect.
Establish relationships with other Parenteral sites, provide technical suggestions, study and benchmark other sites’ EM experiences and adopt into Suzhou site.
Help team member understand the environmental monitoring and clean utility system monitoring processes that impacted product quality and identify the related risks. Provide technical support on EM continuous improvement project.
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 maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and site goals
Ensure environmental monitoring and clean utility system monitoring activities meet data integrity and regulatory requirements.
Provide technical guidance to Operations and other support areas regarding to Sterility Assurance matters and Environmental Monitoring.
- 提供EM数据分析，执行和/或审查和/或批准 EM评估报告以及为批次放行提供审查和批准过的环境监测报告和数据支持。
Provide data analysis for EM data, Perform and / or review and approve EM evaluation reports and data review to support batch release.
Provide technical support for EM initiatives involving viable, non-viable, surface and personnel monitoring. Manage procedural revisions, if needed.
Proactively drive EM projects that support operations, sterility assurance initiatives, and regulatory commitments.
Participate in all the quality operations which to improve sterility assurance.
- 持续关注内外部与环境监测,FUME 和无菌保证相关的标准，为GMP合规和注册提供支持。
Keep eyes on applicable internal and external standards for environmental monitoring, FUME and sterility assurance to support GMP compliance agenda and regulatory submissions.
Keep connection with other sites’ EM technical expert and provide support for Suzhou site EM continuous improvement project.
Perform and / or review and approve root cause investigation of Sterility Assurance and EM non-conformances.
Maintain open communications and promote teamwork and employee participation and communicate in the work group with other departments.
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, preferred with previous experience in Pharmaceutical QC
Strong organization skills and the demonstrated ability to develop a plan and drive the timely execution.
Experience with data trending and analysis,Problem solving and decision-making skills, with emphasis on data-based decisions
Strong technical writing skills and proficiency in technical review of documents
Other Information: Include any work schedule (shift, overtime), travel or environment requirements necessary for the performance of the position.
The position requires to work overtime occasionally and travel as needed.
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-25882.
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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