公司簡介
諾華中國
所屬團隊
職位屬性
- 招聘類型：社招
- 工作性質：全職
職位描述
The Process Expert can work with shopfloor technicians and provide direct front line support to production activities using technical understanding and knowledge of cGMPS, SOPs, and process steps. This individual is accountable to support Manufacturing activities, develop training materials for production operators, train production staff, support process issues, protocol generation, general documentation support, deviation investigations, CAPA ownership, change record ownership, and continuous improvement of the process.
Major Activities
?Support a culture of safety, quality, diversity, and inclusion.
?Work with shopfloor technicians and provide front line support to manufacturing shifts to ensure safe, quality, and timely completion of product batches.
?Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
?Track and trend critical process parameters and in process checks as the lead for ongoing process verification (OPV) and identify CAPAs to address any trends.
?Identify, assess, and own technical changes through GMP change control processes.
?Investigate deviations and determine root causes and identify CAPA.
?Act as Subject Matter Expert (SME) for the product and process knowledge and provide input to the Annual Product Review.
?Ensure processes are inspection ready at all times.
?Support continuous improvement through identification of opportunities, technologies, and owning changes to implement improvements.
?Support validation protocol generation and execution.
?Support on going self-learning and ensuring training is up to date.
?Provide guidance and support to production team through training and knowledge sharing.
?This position will involve wearing protective clothing and working in a Manufacturing Grade C clean room environment.
?This position may require shift work including weekends and off hours support.
?Strong interpersonal, written, communication skills along with problem solving and follow-up skills.
?Well organized, flexible and work with minimal supervision.
Education
Bachelor’s degree in engineering, Pharmacy, Pharmaceutical Technology, Chemistry or other science related field
Language
Proficiency in Chinese and advanced English in listening/speaking/reading/writing
Experience
Minimum requirements:
3+ years of experience in a GMP, R&D, or related Biopharmaceutical environment
1+ years of experience in a process support role in manufacturing
Continuous Improvement Methodology
為什么選擇諾華：幫助患者及家屬不僅需要創(chuàng)新科學,，還需要一支包括你我他在內的充滿智慧與激情的團隊，大家相互協作,、支持與激勵,。共同實現突破，改變患者的生活,。一起共創(chuàng)更好的未來,，你準備好了嗎？
加入我們的諾華網絡：這不是您心儀的職位,？歡迎加入諾華人才社區(qū),，與我們保持聯系，及時了解合適的職業(yè)機會,。您也可以關注諾華集團招聘微信公眾號及諾華集團招聘微信視頻號,。
薪酬與福利：您可以前往諾華官網了解我們幫助您實現個人與職業(yè)發(fā)展的舉措。
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任職條件
the same as above