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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.
The QA Specialist will support day-to -day Quality Assurance activities in accordance with approved SOPs Policies for a multi-product, cGMP contract manufacturing facility in Quality Compliance (External).
Responsibilities
Support day-to -day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGMP contract manufacturing facility
A good understanding of cGMPs and compliance in a GMP manufacturing setting performing both supervised and unsupervised tasks.
Receive minimal supervision and able to perform independently on routine assignments.
Revise, review and approve SOPs, protocols, reports or records
Make real-time decisions on process events on the floor based on knowledge of defined SOPs & policies.
Demonstrate appropriate interpersonal skills which encourage collaboration of individuals or teams to meet objectives.
Develop skills as an internal GMP auditor, as required.
Provide support in backroom / front room in regulatory inspections and customer audits as required.
Participate in walk down and provide usable feedback as required
Assist in audit / inspection response as required.
Review deviation investigations, change controls and CAPA plans as required.
Perform material release and qualification, joint inspection to identify material defect and review/ approve vendor’s investigation report as required.
Leads and coordinate projects and manage the deliverables effectively.
Develop skills to be Qualified Trainer in area of expertise.
Any other tasks as and when assigned by supervisor .
Education / Experience
Diploma / Degree or higher from recognized institution with at least 2 years’ experience in Pharmaceutical industry.
Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICH Guidelines)
Good knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
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.
