Specialist 2, Validation
Singapore, Tuas Singapore
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there is 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.
The Quality Specialist will be responsible to provide day-to-day Quality Assurance activities support in accordance with approved SOPs / Policies for a large scale GMP Biotech manufacturing facility.
- Support day-to-day Validation activities in accordance with approved Validation SOPs /Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility
- Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation / closure
- Participate in Site Validation Maintenance Program
- Participate in commissioning activities when required
- Prepare and review Turnover / Vendor Packages & associated reports
- Support Change Implementation on site
- Support Validation / QA Audits as required, including Material Traceability Audits
- Support Customer / Agency Audits and Inspections as required
- Any other tasks as and when assigned by supervisor.
- Bachelor Degree with exposure in the Biopharmaceutical industry
- Relevant experience from the Biopharma or any related environment
- Hands-on experience coordinating & interacting with internal departments on manufacturing activities
- Knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
- Meticulous and Systematic
- Team player, with strong focus on safety, quality and timelines.
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.