广州招聘

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

You will be responsible for the development and/ or revision of Master Batch Records (MBRs) and other current Good Manufacturing Practice (cGMP) documents e.g. Standard Operating Procedures (SOPs), Work Instructions (WIs) used in the execution of manufacturing processes and/ or operations. The individual should work very closely with Subject Matter Experts (SMEs) in Manufacturing Sciences and Technology (MSAT), Manufacturing (MFG), Quality Assurance (QA), Quality Control (QC), Validation (VAL) and any other relevant departments.

Key responsibilities:

？ Develop new MBR (Master batch record)s, using existing MBR templates, in support of Technology Transfers

？ Maintain currency of MBRs for existing customers

？ Produce high-quality documentation that meets applicable standards/ requirements of the users

？ Write and edit technical information/ instructions in a manner to ensure content is factual and accurate

？ Meet with SMEs to ensure specialized topics are appropriately addressed/ discussed

？ Collaborate closely with relevant SMEs from various disciplines on documentation requirements

？ Manage the lifecycle of MBRs including, but not limited to creation, review, revision and approval of MBRs on product campaign basis

？ Maintain a system for tracking changes to be implemented in all upcoming product campaigns

？ Ensure MBRs adhere to approved template/ structure

？ Communicate actively to address customers’ comments and to clarify customers’ queries with respect to MBRs

？ Support change controls, deviations and introduction of New Stock Items (NSI)

？ Address comments arising from internal reviews and revise the documents accordingly.

？ Deliver MBRs with strict adherence to the production schedule

？ Provide assessments and insights to Change Requests from Technical Writing Team (TWT) perspective

？ Define Change Tasks associated with TWT

？ Ensure assigned CAPAs and Change Tasks are closed in a timely manner

？ Attend planning and briefing meetings

？ Perform any other duties as assigned by your Lead / Manager

Key requirements:

？ BS in Engineering (Chemical/ Biochemical) or Science (Biochemistry/ Chemistry/Microbiology) related disciplines preferred

？ Work experience in a cGMP regulated environment and prior technical knowledge in biopharmaceutical processing will be an advantage

？ Strong technical communication and writing skills

？ Excellent oral presentation skills

？ Effective interaction skills with MSAT, MFG, QA, customers and auditors

？ Strong proficiency in standard Microsoft Office applications e.g. MS Word and MS PowerPoint

？ Advanced knowledge in Controlled Document Management System (DMS)

？ Track record in completing projects under tight timelines

？ Ability to quickly grasp and translate complex technical concepts to comprehensible instructional texts

？ Ability to influence peers and teams with no direct reporting lines

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza龙沙是全球医药、生命科学及营养保健领域的领先供应商之一。龙沙制药与生物技术业务提供全球化合同定制开发与生产(CDMO)服务，使制药与生物技术公司能为患者带来医学创新。龙沙以高信任度、高质量、全球产能、创新技术平台以及广泛的经验而备受认可。龙沙经营的项目涵盖从前期临床开发到商业化生产的全部过程，涉及哺乳动物和微生物的生物制品、小分子、生物偶联物、细胞和基因疗法等领域。

龙沙位于广州的生物技术生产基地将投入运营，提供临床前到早期商业化的开发和生产服务，以应对国内不断增长的高质量定制的需求。