Lonza Logo

Lonza

Lead Specialist, QA Audit (CGT)

Posted 12 Hours Ago
Be an Early Applicant
In-Office
Singapore, SGP
Senior level
In-Office
Singapore, SGP
Senior level
Lead QA Audit Specialist to support audit activities and GMP/cGxP compliance at a multi-product contract manufacturing site. Responsibilities include internal GxP auditing, inspection and customer audit support, audit walkdown preparation, audit/inspection responses, leading complex deviation investigations, owning assigned quality process documents, and serving as subject-matter expert and trainer.
The summary above was generated by AI

 

The Lead QA Audit Specialist will support Audit activities in accordance with approved SOPs / Policies for a multi-product, cGxP contract manufacturing facility

Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

This is a fully sitebased role. Working together in person supports close, realtime collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

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: www.lonza.com/careers/benefits

What you’ll do

  • Develop skills as an internal GxP auditor, as required

  • Provide support in backroom / front room in regulatory inspections and customer audits as required

  • Lead in audit walk down preparation and provide feedback as required

  • Lead in audit / inspection response as required.

  • Lead in complex deviation investigations as required.

  • Owns documents of the assigned Quality Process when applicable

  • Develop skills to be Qualified Trainer in area of expertise

  • Subject Matter Expert in one or more area of expertise

What we’re looking for

  • Bachelor’s degree with relevant experience in Quality Assurance within the biopharmaceutical sector.

  • Proven experience in QA operations in a GMP-regulated biopharma environment.

  • Practical experience collaborating with cross-functional manufacturing teams.

  • Solid understanding of quality management systems and GMP compliance requirements.

  • Familiarity with regulatory guidelines such as FDA, EMA, and ICH.

  • Strong analytical, problem-solving, communication, and organizational abilities.

  • Detail-oriented, structured, and a strong team player with a focus on safety, quality, and meeting timelines

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.

Lonza Singapore, Singapore, SGP Office

Singapore, Singapore

Similar Jobs

An Hour Ago
In-Office
Singapore, SGP
Senior level
Senior level
Artificial Intelligence • Hardware • Information Technology • Machine Learning
Lead the NAND product development team, focusing on driving product development strategies, cross-functional collaboration, and adoption of AI-enabled workflows to enhance performance and execution.
Top Skills: Ai PlatformsData-Driven ApproachesNand Technology
An Hour Ago
In-Office
Singapore, SGP
Senior level
Senior level
Artificial Intelligence • Hardware • Information Technology • Machine Learning
As a Senior Member of Technical Staff, you'll lead the development and integration of 3D NAND processes, focusing on innovation, performance optimization, and cross-functional team coordination.
Top Skills: Power BIPythonSolidworksTableau
An Hour Ago
In-Office
Singapore, SGP
Expert/Leader
Expert/Leader
Artificial Intelligence • Hardware • Information Technology • Machine Learning
Lead the NAND Module Process Integration, improving 3D NAND product yield and quality while developing module specifications, optimizing processes, and innovating solutions.
Top Skills: Power BIPythonSolidworksTableau

What you need to know about the Singapore Tech Scene

The digital revolution has driven a constant demand for tech professionals across industries like software development, data analytics and cybersecurity. In Singapore, one of the largest cities in Southeast Asia, the demand for tech talent is so high that the government continues to invest millions into programs designed to develop a talent pipeline directly from universities while also scaling efforts in pre-employment training and mid-career upskilling to expand and elevate its workforce.

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account