Lonza Logo

Lonza

Specialist 3, QA Operations (Master Batch Record)

Reposted 3 Hours Ago
Be an Early Applicant
In-Office
Singapore
Mid level
In-Office
Singapore
Mid level
The QA Specialist will oversee Quality Assurance activities, manage product status, investigate deviations, prepare release documentation, and ensure compliance in a GMP facility.
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.

As a QA specialist you will provide day to day Quality Assurance activities support in accordance with approved SOPs/Policies for a large scale GMP Biotech 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: www.lonza.com/careers/benefits

What you’ll do

  • Review batch records/logbooks and escalate deviations promptly.

  • Prepare lot genealogy and disposition packages for product release.

  • Oversee product status, shipping documentation, and the quality tag-out system.

  • Participate in and approve deviation investigations using RCA tools; monitor CAPA execution and closure.

  • Escalate shop floor events per SOPs and support compliant changeover activities.

  • Provide quality oversight for MBRs, SOPs, forms, logbooks, and quality change requests.

  • Identify cGMP non-compliance and recommend corrective actions.

  • Conduct shop floor walk-downs and support regulatory inspections/audits.

  • Lead team projects and build strong stakeholder relationships.

  • Act as Change Agent/Reviewer/Approver for SOPs, protocols, reports, and records.

  • Support management of deviations and change controls.

What we’re looking for

  • Degree with 2-5 years of experience in a in a similar type of industry or a similar job role.

  • Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).

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

  • Pleasant personality.

  • Good oral and written communication skills.

  • 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.

Top Skills

Gmp
Quality Management Systems
Rca Tools

Lonza Singapore Office

35 Tuas South Ave 6, Singapore, 637377

Similar Jobs

3 Hours Ago
In-Office
Singapore, SGP
Senior level
Senior level
Artificial Intelligence • Fintech • Payments • Business Intelligence • Financial Services • Generative AI
The Senior Manager will oversee model governance and data standards, ensuring compliance, developing frameworks, and validating models and data quality.
Top Skills: AlationCollibraInformaticaMs-ExcelPower BIQlikSQLTableau
3 Hours Ago
In-Office or Remote
Singapore, SGP
Senior level
Senior level
Blockchain • Fintech • Payments • Financial Services • Cryptocurrency • Web3
The Senior Counsel will provide legal support for compliance, governance, regulatory matters, and risk management, while collaborating with cross-functional teams.
Top Skills: Apple MacosGoogle SuiteSlack
3 Hours Ago
In-Office or Remote
Singapore, SGP
Senior level
Senior level
Blockchain • Fintech • Payments • Financial Services • Cryptocurrency • Web3
The Director of APAC Operations will lead strategic growth and operational excellence in the APAC region, oversee market entry, and work cross-functionally with teams to launch and manage operations while liaising with stakeholders.
Top Skills: CodaGoogle SuitemacOSSlack

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