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 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.
Join our best-in-class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting-edge biotechnology and innovation. Learn new skills and capabilities. Grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.
The QA Specialist will be responsible to provide oversight to manufacturing in a large scale, multi-product, GMP biotech contract manufacturing facility.
What you will get
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
Daily company bus from the MRT location near your home to and from the Tuas site.
Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do
- Support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, GxP contract manufacturing facility
Take on role of QA Specialist in one of 6 areas: Quality Systems, QA Engineering, External QA, QA Excellence (Transformation and Technical Compliance), Quality Operations or Audit Management. • In depth awareness of entire process; identifying operational factors which influence the process
Lead a small team and provides supervision to QA Coordinators, interns or QA Specialists 1 and 2
A competent Reviewer and Approver of SOPs, protocols, reports or records
Review of batch records and logbooks, perform changeovers, populate lot genealogy for Lot Disposition and customer supports.
Can trouble-shoot and able to weigh up all information and consideration in order to choose the optimum path to be taken.
Demonstrate ability to lead a small project and manage the deliverables effectively.
Develop good working relationships with internal & external customers.
Able to participate actively or lead in deviation investigations, change controls, CAPA plans and closure of discrepancy reports.
Develop skills as an internal GxP auditor, as required.
Provide support in regulatory inspections and customer audits as required.
Plan for future activities and coordinate with other departments to complete this • Develop skills to be Qualified Trainer in area of expertise.
Any other tasks as and when assigned by supervisor.
What we are looking for
- Bachelor's degree with relevant work experience in Quality Assurance in the Biopharmaceutical industry.
Relevant QA Operations background from the Biopharma environment.
Hands-on experience coordinating & interacting with internal departments on manufacturing activities.
Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
Familiarity with Regulatory requirements and local Codes & Standards (e. g., FDA, EMEA, andlCHQ7).
Meticulous and Systematic.
Team player, with strong focus on safety, quality and timelines.
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.
Top Skills
Lonza Singapore Office
35 Tuas South Ave 6, Singapore, 637377
