職位描述
職位描述：
職位描述/ Description:
?Primary responsibility is operational work on Fill&Finish process under GMP conditions for Oasis facility (and BioLab where applicable), focusing on aseptic filling operations including material preparation, formulation, sterile filtration, sampling, aseptic filling line operation, visual inspection, manually filling, in both non-GMP and GMP area.
?Organize Fill&Finish documents. Create relevant documents (e.g. SOP, BPR, etc. ) and review if required. Support updating the current documents on site.
?Coordination and planning of equipment to ensure timely material supply. Support ensuring cGMP readiness of facility and equipment (e.g. support on performing of calibration and maintenance of equipment).
?Support and participate in qualification and validation to ensure the production plan can be finished in time.
?Performing documentation of process transfers from internal and external clients, as well as Fill&Finish CMO (e.g. Compilation of DP, Process transfer, etc.).
?Act as “Person-in-plant” (PiP) for Operations onsite at the 3rd party CMO if required.
?Responsible for processing of economic and robust formulation and filling and freeze-drying processes for therapeutic proteins and monoclonal antibodies by applying state of the art technologies to ensure manufacturing of bulk drug product.
?Being part of process transfer teams to secure material supply for projects to support Tox and clinic studies.
崗位職責/ Duties & Responsibilities:
?Perform aseptic handling and processing, optimization and scale-up to meet all quality and regulatory demands. Work under good GMP awareness. Support project transfer from internal and external clients. Carry out pre-clinical and clinical manufacturing of Drug Product.
?Handle operational work packages within the team including change-over, formulation, filling, freeze-drying, visual inspection, packaging and in-process controls.
?Organize Fill&Finish documents. Create relevant documents (e.g. SOP, BPR, etc. ) and review if required. Support updating the current documents on site.
?Support and participate in qualification and validation to ensure the production plan can be finished in time.
?Exchange actively with colleagues in order to ensure best-practice sharing and best use of resources in accordance with the supervisor. Mentoring new staff.
?Supporting trouble shooting from production point of view. Lead and/or support on Fill&Finish related quality events (e.g. DV, INV, CAPA, Change Control, etc.) when needed. Work under good GMP awareness.
?Ensuring good communication, material and data handover with internal and external customers and interfaces as DSP, QC, R&D, and transfer partners.
職位要求/ Requirements:
?Bachelor/Master degree, with major in Pharmacist, Biopharmaceutics, Biotechnology, Biochemistry
?Experience in aseptic processing and Fill&Finish operations in a cGMP environment
?Basic knowledge and general understanding of cGMP and documentation according to cGMP
?Good understanding and practical experience in organizing a lab
?Practical experience with Fill and Finish cGMP operations and analytical technologies (e.g. chromatography, filtration, spectrometry, etc.).
?Analytical and scientific thinking, clear argumentation and ability to reduce complex issues to the main points
?Self confidence
?Social competence, customer orientation and team player
?We are seeking to recruit a person who offers direct relevant operational experience in aseptic cGMP manufacturing within a biopharmaceutical company.
?This individual will work hands-on in a cGMP manufacturing site and also perform cGMP documentation, shift work will occur on periodic basis.
更多勃林格殷格翰職位，請點擊此處。
To know more positions in Boehringer Ingelheim, please click here.
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勃林格殷格翰微信公眾號/ Boehringer Ingelheim Wechat: JoinBI
勃林格殷格翰中國/ Click to access Boehringer Ingelheim China: http://www.boehringer-ingelheim.com.cn/
勃林格殷格翰全球/ Click to access Boehringer Ingelheim Global:
http://www.boehringer-ingelheim.com/
參觀勃林格殷格翰中國總部：www.visitbi.cn
公司介紹/ Company Introduction：
從1885，成立于德國小鎮殷格翰的家族工廠到遍布全球的知名制藥企業。勃林格不斷創新，為全世界患者造福。 自1994年起，勃林格扎根中國已經將近20年。我們的員工隊伍也在不斷壯大，大家正凝聚力量，蓄勢待發!
我們期待您的加入！
我們的使命
致力于在提供創新且高質量的藥物及健康解決方案方面與眾不同，從而為提高人們的整體健康生活水平做出卓越的貢獻。
我們的價值觀
尊重 – 相信人人都能帶來價值。
信任 – 永遠言出必行 。
同理心 – 理解并關懷他人。
熱情 – 凡事力爭卓越。
我們的愿景：成為大中華區首屈一指的跨國制藥企業。
Since 1885, from a family-owned business founded in Ingelheim, Germany to a truly global pharmaceutical company. Boehringer Ingelheim’s continuous innovations are surely benefiting the patients throughout the world.
Boehringer Ingelheim has rooted in China for nearly 20 years since 1994. Our employees are rapidly growing as well. Stronger, Together!
Welcome to join Boehringer Ingelheim !
Our Mission
We will make a difference to improve the quality of health and life in China and HK through our unwavering commitment to innovation and delivering high quality healthcare solutions.
Our Values
Respect – Everyone inherently brings value.
Trust – We always do as we say.
Empathy – We understand and we care about people.
Passion – To excel in everything we do.
Our Vision: To become the Premier Multinational Pharmaceutical Company in the Chinese market (T.C.M)
