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 Singapore? 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.
Key responsibilities:
- Manage day-to-day Quality Assurance activities to ensure that product has been manufactured and tested in accordance with cGMP requirements, company SOPs, policies and specifications.
- Has knowledge of cross-functional QA roles and make Quality decisions based on the knowledge/experience.
- Involvement in review of Policies.
- Review/Approve SOPs, protocols, reports, deviation investigations, change controls, CAPA proposals and discrepancy reports.
- Supervise, train, develop staff to support QA activities.
- Perform product/Material dispositions
- Involvement in harmonization/ efficiency projects; lead local/global projects for implementation. Work within the Lonza Global network to share best practices/learnings.
- Contribute to development and control of departmental budget and capital expenditures and resource planning.
- Act as a designee for Head of Quality-CGT
- Lead a team of Quality Specialists and perform appraisal for the team members.
- Designee for Head of Quality – Cell & Gene Technology to perform final lot disposition of Drug Product /Drug Substance in CGT and assure that product has been manufactured and tested in accordance with cGMP requirements, company SOPs, policies and specifications.
- Any other tasks as and when assigned by the Supervisor.
Key requirements:
- Degree from recognized institution
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities
- Good knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
- Good leadership skills
- Exhibit good quality decision making traits
- Meticulous and Systematic
- Analytical Mind
- Ability to define specific goals clearly, to develop and prioritize activities
- 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 achieve 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.
