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Today, Lonza is a global leader in life sciences operating across three 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.
Did you know that we are the 1st biologics contract manufacturer in ? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.
As a QA Expert you are responsible for providing technical expertise for all testing techniques and coordinating with the other customers and other departments to deliver projects in a timely manner.
Responsibilities
Effectively manage multiple priorities, ensuring smooth execution of various tasks.
Collaborate with tech transfer teams to introduce new processes or modify existing ones, serving as the lab’s designated representative.
Lead and manage complex special projects, coordinating project teams to ensure successful completion.
Ensure accurate collection, distribution, and communication of project information to clients and internal teams.
Oversee communication planning, information distribution, project performance reporting, and project closure processes.
Provide regular updates on project status to stakeholders, offering key insights.
Collaborate with different departments to improve communication and resolve compliance or documentation issues.
Author protocols and reports for method transfer, qualification, validation, stability, or investigations, when applicable.
Participate in product stability programs, including tasks like stability pulls, shipment arrangements, and setting up stability LIMs.
Contribute to annual product reviews and other regulatory documentation.
Advise junior staff on scheduling and resolving technical problems.
Ensure that projects are completed within budget, managing resource planning, cost estimation, budgeting, and control.
Act as the point of contact between clients, quality control, and management, coordinating project budgets and resources.
Manage the preventative maintenance and requalification of stability-related equipment, like temperature chambers.
Ensure proper coordination of all project elements, including project plan development, execution, and change control.
Facilitate cross-functional integration of activities within the project team.
Provide expert planning and operational support throughout the project lifecycle.
Contribute to development and production planning as well as other project-related documentation.
Support audit activities when needed.
Perform other tasks as assigned by the Manager.
Experience:
Bachelor’s or Diploma in a relevant science field or equivalent.
Minimum of 10 years of experience in GMP (Good Manufacturing Practice) Quality.
Relevant work experience, preferably in a laboratory setting, within the biotech or medical field.
Individual contributor, high level understanding of QC activities and lab function
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.
