Today, Lonza is a global leader in life sciences operating across five continents. 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.

What you will do:

• Attain good understanding on current Good Manufacturing Practice (cGMP) and its application

• Support MCO day-to-day activities according to Environment, Health and Safety (EHS) guidelines and in a compliant manner

• Work on the development and / or revision of Master Batch Records (MBRs) which will be used in the execution of manufacturing processes

• Make use of other GMP documents such as Standard Operating Procedures (SOPs), logbooks and protocols in developing and / or revision of MBRs

• Manage document life cycle using an electronic Document Management System (DMS)

• Implement Corrective and Preventive Action (CAPAs) and Change Request changes using a quality management system

• track the review status of documents and drive the progression to achieve on time delivery

• Collaborate closely with relevant Subject Matter Experts (SMEs) from various disciplines on documentation requirements

• Address comments arising from internal and external stakeholders and revise the documents accordingly

• Support with the provision of GMP documents, data mining of historical information to aid with the investigation

• Perform recurrence analysis for deviations

• Shadow MCO members during investigation and closure of deviations

• Complete deviation reports, which includes but not limited to root cause analysis utilizing standard methodologies e.g. 5-Whys, Ishigawa Diagrams, causal branching, event and causal factor charting, Failure Mode, Effect and Cause Analysis (FMECA), product/ quality impact assessment/ justification and design of appropriate CAPA(s) with effectiveness checks, where required

• Participate in receival of batch records, ensuring all dispensing sheets and batch records are in suite prior to production use 

• Organize and plan assigned daily activities to ensure timely completion of assignments

• Perform data mining, interpret and present data to support continuous improvement projects with adherence to the respective project timelines

• Identify areas of improvement within MCO and to support other sub-functions within MCO as required

• Perform any other duties as assigned by Supervisor / Manager

What we're looking for:

• Currently enrolled in a Degree/Diploma in a relevant field of study i.e.Chemical Engineering, Biotechnology

• Keen interest in the field of biomedical sciences

• Passionate, willing to learn and with a keen eye for detail

• Working knowledge of the MS Suite

• Strong communication skills and an ability to collaborate with cross functions

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 is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.