Senior Specialist, QA

5 days ago

Singapore Lonza Biologics Tuas Pte Ltd Full time

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. As a Senior QA Specialist will support day-to-day Quality Assurance activities in accordance with approved SOPs / Policies for a multi-product, cGMP contract manufacturing facility. 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'll get An agile career and dynamic working culture in a global life sciences leader. An inclusive and ethical workplace that values diversity and integrity. Competitive compensation programs that recognize high performance. Professional growth opportunities through cross-functional projects and global exposure. Comprehensive medical insurance, with the option to enroll family members at partially subsidized premiums. Company transport provided from designated MRT locations to and from the Tuas site. Access to Lonza's full suite of employee benefits: What you'll do Provide QA oversight to QC/DS lab services including review of documents and Trackwise records such as PQRs, BLA content, new product introductions, gap assessments, and customer suspension/decommissioning activities. Participate actively in cross-functional site teams addressing various projects and operational issues. Lead or support improvement initiatives and strategic process development efforts. Lead or contribute to complex investigations involving deviations, change controls, CAPA proposals, and discrepancy reports, applying Root Cause Analysis tools to ensure timely and effective resolution. Support regulatory inspections and customer audits, confidently representing QA as a subject matter expert. Key Requirements Bachelor's degree or higher in Life Sciences or Pharmaceuticals, with significant experience in Validation and Quality roles within the Biopharmaceutical industry. A team player with 5+ years of relevant experience in a similar industry or role. Thorough understanding of regulatory requirements and local codes and standards (e.g., FDA, EMEA, ICHQ7). Practical and theoretical experience in quality management systems within GM facilities. 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. #J-18808-Ljbffr

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