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.
As a QA specialist you will provide day to day Quality Assurance activities support in accordance with approved SOPs/Policies for a large scale GMP Biotech Manufacturing facility.
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.
What you’ll get
An agile career and dynamic working culture in a global life sciences leader.
An inclusive and ethical workplace that values diversity and integrity.
Competitive compensation programs that recognize high performance.
Professional growth opportunities through cross-functional projects and global exposure.
Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums.
Company transport provided from designated MRT locations to and from the Tuas site.
Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits
What you’ll do
Review executed batch records and logbooks, ensuring timely identification and escalation of deviations.
Compile lot genealogy and prepare lot disposition packages to drive efficient product release.
Oversee product status and coordinate documentation required for shipping activities.
Manage and provide oversight of the quality tag-out system.
Actively participate in and approve deviation investigations, applying Root Cause Analysis (RCA) tools to ensure effective and timely closure.
Monitor CAPA implementation, verifying proper execution and closure within defined timelines.
Escalate process events on the shop floor in alignment with established SOPs and policies.
Support changeover activities and ensure compliance during transitions.
Provide quality oversight for operations-related documentation, including MBRs, SOPs, forms, and logbooks.
Review and oversee quality change requests related to processes and operations.
Identify non-compliance with cGMP requirements, providing guidance and corrective actions as needed.
Participate in shop floor walk-downs/QA presence and provide actionable feedback.
Support and participate in regulatory inspections and customer audits.
Lead and coordinate team projects, ensuring deliverables are met effectively.
Build strong working relationships with internal and external stakeholders.
Demonstrate problem-solving skills with the ability to evaluate information and determine optimal solutions.
Act as a Change Agent, Reviewer, or Approver for SOPs, protocols, reports, and records.
Assist in managing deviation investigations and change controls.
What we’re looking for
Degree with 1-3 years of experience in a in a similar type of industry or a similar job role.
Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.
Pleasant personality.
Good oral and written communication skills.
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.