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Lonza

Specialist 3, QA Operations (Lot Release)

Reposted 9 Days Ago
Be an Early Applicant
In-Office
Singapore
Senior level
In-Office
Singapore
Senior level
The role involves providing QA oversight in a GMP facility, reviewing and approving documentation, leading deviations and CAPAs, troubleshooting quality issues, and ensuring process improvements and compliance.
The summary above was generated by AI

 

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.

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 will get

  • An agile career and dynamic working culture.

  • An inclusive and ethical workplace.

  • Compensation programs that recognize high performance.

  • Daily company bus from the MRT location near your home to and from the Tuas site.

  • Fully paid medical insurance, and option to enroll family members at partially subsidized premiums.

  • Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do

  • Perform day-to-day QA oversight in a multi-product GMP facility.

  • Review and approve SOPs, protocols, reports, batch records and batch disposition.

  • Lead or participate in deviations, change controls, and CAPAs.

  • Troubleshoot quality issues using risk-based decision-making.

  • Build strong partnerships with manufacturing, QC, and support teams.

  • Plan and coordinate cross-functional activities to meet timelines.

  • Uphold data integrity; identify and implement process improvements.

What we are looking for

  • Bachelor’s degree in chemical, Biomedical, or related Engineering.

  • 5+ years’ QA experience in GMP biopharma or similar regulated environment.

  • Working knowledge of FDA, EMA, and ICH Q7 guidelines.

  • Proven experience with deviations, CAPAs, and change control.

  • Strong written and verbal communication; collaborate across functions.

  • Organized, meticulous, and systematic; prioritize safety, quality, and timelines.

  • Ability to lead small projects and train others in area of expertise.

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.

Top Skills

Ema
Fda
Gmp
Ich Q7

Lonza Singapore Office

35 Tuas South Ave 6, Singapore, 637377

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