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羅氏促進(jìn)多元化、公平性和包容性，代表我們所服務(wù)的社區(qū)。在全球范圍內(nèi)處理醫(yī)療保健問題時(shí)，多元化是成功的關(guān)鍵因素。我們認(rèn)為，包容性是理解人們不同醫(yī)療保健需求的關(guān)鍵。我們共同擁抱個(gè)性，共同抱持對(duì)卓越護(hù)理的熱情。加入羅氏，每個(gè)聲音都會(huì)得到重視。
職位
1. Lab Establishment and Setup:
Lead the setup and validation of the new QC laboratory:
* Define the scope and requirements for lab infrastructure and layout.
* Select appropriate lab equipment and instruments, ensuring they meet the
necessary technical specifications and compliance standards.
* Arrange the installation and qualification of lab equipment including
IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance
Qualification).
Oversee laboratory layout design:
* Develop an efficient and compliant lab layout that adheres to GMP
requirements and supports optimized workflow.
* Ensure that lab workstations, storage areas, and other lab spaces are
designed to prevent cross-contamination and ensure safety.
Develop and implement standard operating procedures (SOPs):
* Create and document SOPs covering all aspects of lab operations, including
equipment use, maintenance, safety protocols, and testing procedures.
* Ensure that SOPs are regularly reviewed and updated in line with regulatory
changes and best practices.
2. GMP System Development:
Establish and maintain a robust GMP system:
* Develop and implement a comprehensive GMP framework that includes all
aspects of lab management and operations.
* Ensure that QC processes align with GMP requirements to guarantee product
quality and safety.
Develop and implement quality control procedures and protocols:
* Design and document detailed QC procedures for sample testing, handling,
and storage.
* Implement protocols for method validation, calibration, and testing
consistency.
Ensure proper documentation practices:
* Maintain accurate and complete records of all lab activities, including
test results, equipment logs, and compliance documentation.
* Establish data integrity practices to ensure that all records are reliable
and traceable.
3. Regulatory Compliance and Quality Assurance:
Ensure compliance with regulatory requirements:
* Ensure all lab operations comply with relevant regulatory standards (e.g.,
FDA, EMA, and other international guidelines).
* Stay updated on changes in regulations and industry standards to ensure
ongoing compliance.
Coordinate and support for audits and inspections:
* Prepare the lab for internal and external audits and inspections by
regulatory bodies.
* Collaborate with the qulity department to manage audit findings and
implement corrective actions.
Investigate and resolve quality-related issues:
* Perform root cause analysis for any deviations, out-of-specification
results, or laboratory incidents.
* Develop and implement corrective and preventive actions (CAPAs) to address
and prevent quality issues.
4. Collaboration and Communication:
Collaborate with cross-functional teams:
* Work closely with RA, Manufacturing, engineering and QA teams to support
the transfer and commercialization of biological drug products.
* Provide QC expertise to support product development, process optimization,
and troubleshooting.
* Communicate effectively with stakeholders
* Provide regular updates to internal and external stakeholders on lab
activities, project progress, and compliance status.
* Foster strong relationships with external partners and regulatory
authorities to facilitate cooperation and compliance.
5. Other business activities：
Understand and support day-to-day operations of the QC lab:
* Regularly review lab performance metrics and KPIs to identify areas for
improvement.
* Implement continuous improvement initiatives to enhance lab processes and
productivity.
* Leadership and project management
* Promote members to complete tasks according to project goals
* Have project node awareness and risk awareness, and actively communicate
with project-related personnel, such as project stakeholders and project
members.
* As the project manager, manage project conflicts, manage risks, and drive
project implementation.

我們是誰
在羅氏，來自100個(gè)國家的100，000名員工不斷推動(dòng)著健康醫(yī)療行業(yè)的進(jìn)步。我們一同工作，使羅氏成為了世界領(lǐng)先的以研發(fā)為基礎(chǔ)的健康醫(yī)療集團(tuán)。我們的成功源于創(chuàng)新、求知和多元化，也源于我們把相互間的差異作為一種優(yōu)勢(shì)。為了革新醫(yī)療健康領(lǐng)域，羅氏設(shè)定了遠(yuǎn)大的計(jì)劃，堅(jiān)持學(xué)習(xí)和發(fā)展，并不斷尋找與之志同道合的伙伴。
羅氏中國由制藥和診斷兩大業(yè)務(wù)領(lǐng)域組成，員工總數(shù)超過7000人。作為全球個(gè)體化醫(yī)療的領(lǐng)導(dǎo)者，羅氏制藥和羅氏診斷均在中國建成了完整的價(jià)值產(chǎn)業(yè)鏈，包括研究、開發(fā)、生產(chǎn)、營銷等環(huán)節(jié)。未來，上海將成為羅氏繼巴塞爾和舊金山之后的第三大全球戰(zhàn)略中心，而羅氏也將繼續(xù)踐行對(duì)中國的長期承諾，滿足中國患者的未盡之需。
羅氏提供平等的職業(yè)發(fā)展機(jī)會(huì)。