Specialist 2, Validation and Technical Compliance, QA

Specialist 2, Validation and Technical Compliance, QA

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’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.

Provide QA oversight for QC / DS lab services, including review and approval of protocols, reports, deviations, discrepancies, and CAPA implementation.

Apply Root Cause Analysis tools to ensure effective and timely closure of quality records.

Oversee Quality Change Requests related to lab service changes.

Collaborate with cross-functional teams, ensuring timely communication and updates.

Build strong working relationships with internal and external stakeholders.

Participate in cross-functional walkdowns and provide QA feedback.

Lead and coordinate projects, ensuring deliverables are met.

Develop capabilities as a Qualified Trainer and support audits as an SME for QA oversight.

What we’re looking for

Bachelor's degree with significant years’ experience in Quality Assurance in the Biopharmaceutical industry.

Familiarity with Regulatory requirements and local Codes & Standards (eg. FDA, EMA and ICH Quality Guidelines)

Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility.

Able to operate independently with minimum supervision for routine work within established policies and procedures and receives detailed instructions on new projects and assignments.

Meticulous and Systematic.

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 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.

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