qc質量工程師

1.
Position Details職位基本信息：
Position Title:
職位名稱:
MD Specialist for Project Support
項目支持主數據專員
Division:
部:
PT Shanghai
上海技術運營部
Reports to:
直接主管:
QC
Business Excellence and Project Lead
QC業務卓越和項目負責人
Department:部門:
Quality / QC
質量部 / 質量控制
Functional Manager:
(Global Functions)
職能經理:
(全球職能部門)
N/A
Location:
工作地點:
HQ, Shanghai
上海總部

2. Primary Purpose of Job (Job Summary)主要工作目標（崗位簡介）
●
Provide services for QC
laboratory electronic system-related processes, including master data
establishment of SAP/LIMS/PS/NEXTLab and
other systems, system information flow and business process management,
system module management, system interface data management, system
confirmation/validation management, etc. Ensure that the establishment and
management of laboratory and quality management related electronic systems can meet business needs and
compliance needs, and comply with Roche GSP/SOP, China GMP&GSP, data
integrity and relevant regulations.
為QC實驗室電子系統相關流程提供服務，包括SAP/LIMS/PS/NEXTLab等系統的主數據建立，系統信息流及業務流程管理，系統模塊管理，系統交互數據管理，系統確認/驗證管理 etc.。確保實驗室和質量管理相關電子系統的建立和管理能夠滿足業務需求和合規需求，符合羅氏GSP/SOP、中國GMP&GSP、數據完整性和有關法規的要求。
●
Provide services for QC
laboratory daily business-related processes, including laboratory control
document management, reagent/reference standards management, stability sample
and release sample E2E management, retained sample management, equipment
qualification management, etc. Ensure that the laboratory's related business
can be carried out in a compliant and orderly manner, support the analysis
process in a controlled state, and comply with Roche GSP/SOP, China
GMP&GSP, data integrity and relevant regulations.
為QC實驗室日常業務相關流程提供服務，包括實驗室受控文件管理，試劑/標準物質管理，穩定性樣品和放行樣品E2E 管理，留樣管理，設備驗證管理等。確保實驗室的相關業務能夠合規有序的執行，支持分析過程處于受控狀態，符合羅氏GSP/SOP、中國GMP&GSP、數據完整性和有關法規的要求。
●
High-standard business support
高標準業務支持

3. Principle Roles & Responsibilities / Accountabilities 主要職責/責任
(Major functions of the position) （職位的首要職能）
●
QC electronic system related System Process and Business
Process R&R :
QC電子系統相關流程職責/責任:
?
Complete the master data
establishment, testing, review, confirmation/validation and other work of SAP/LIMS/PS/NEXTLab and other systems according
to the project plan with quality and quantity.
根據項目計劃保質保量的完成SAP/LIMS/PS/NEXTLab等系統的主數據建立，測試，復核，確認/驗證等工作。
?
Establish the
information flow of SAP/LIMS/PS/NEXTLab and
other systems and actively identify the differences with business processes,
and make optimization suggestions.
建立SAP/LIMS/PS/NEXTLab等系統的信息流并主動識別與業務流程的差異，并提出優化建議。
?
Perform relevant
tests of SAP/LIMS/PS/NEXTLab and other
system interactions.
執行SAP/LIMS/PS/NEXTLab等系統交互的相關測試。
?
Establish the
master data lifecycle management process and work instructions for SAP/LIMS/PS/NEXTLab and other systems
建立SAP/LIMS/PS/NEXTLab等系統的主數據生命周期管理流程和工作指導
?
Assist in establishing the
dynamic data lifecycle management process and work instructions for SAP/LIMS/PS/NEXTLab and other systems
建立SAP/LIMS/PS/NEXTLab等系統的動態數據生命周期管理流程和工作指導
?
Perform system management and
maintenance such as SAP/LIMS/PS/NEXTLab,
provide support to users, solve problems, and ensure the normal operation of
the system
執行SAP/LIMS/PS/NEXTLab等系統管理和維護，為用戶提供支持，解決問題，確保系統的正常運轉。
?
Proactively identify and
propose optimization suggestions for SAP/LIMS/PS/NEXTLab and other systems and implement them.
主動識別并提出SAP/LIMS/PS/NEXTLab等系統的優化建議并實施。
●
Comply
with Roche GSP/SOP, China GMP&GSP, data integrity and relevant
regulations.
符合羅氏GSP/SOP、中國GMP&GSP、數據完整性和有關法規的要求。
●
Complete the other tasks assigned by the leader.
完成上級領導布置的其他任務


4. Qualification and Experience 能力與經驗

Education/Qualifications教育程度/所獲資格證書
●
Bachelor of Science or above
理學士及以上學位
●
Pharmacy, Chemistry,
Biochemistry and related disciplines
藥學、化學、生物化學及相關學科
●
At least 2 years of experience
in pharmaceutical analysis or technical registration or ERP/LIMS
至少2年在制藥企業分析或技術注冊或ERP/LIMS領域工作經驗

Leadership Competencies領導力
N/A

Job Required Competencies崗位所需勝任力
●
Expertise in physical,
chemical and biological analysis
理化生分析專業知識
●
GMP&GSP and Data Integrity
implementation experience and awareness
GMP,GSP和數據完整性實施經驗和意識
●
Expertise in ERP/LIMS/PS
systems related to pharmaceutical companies
制藥企業相關ERP/LIMS/PS系統專業知識
●
Language skills - English and
Mandarin
語言能力-英語及國語


5. Change
History /歷史記錄
Version
Changes
1.0
New
creation/新建