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Senior Specialist, QA (Technical Support )

US0Lonza Biologics Inc.
🇸🇬 Singapore
On-site
Senior
3 weeks ago
  • Agile
  • GMP
  • CAPA
  • Health insurance
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As a Senior QA Specialist, you will support theQA technical support team .

This is a fully site‑based role at Singapore Tuas. Working together in person supports close, real‑time 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:

  • Provide day-to-day QA support for a multi-product cGxP manufacturing facility in accordance with SOPs and policies.

  • Review and approve deviations, investigations, CAPAs, change controls, SOPs, protocols, reports, MBRs, and other GMP documents.

  • Ensure effective root cause analysis, timely CAPA implementation, and closure of quality events.

  • Identify and escalate cGMP/GDocP non-compliance and provide guidance on corrections.

  • Support changeover activities and provide QA oversight for operational and process changes.

  • Participate in regulatory and customer audits.

  • Troubleshoot quality issues and make sound decisions based on risk and available information.

  • Lead small projects and coordinate activities with relevant departments to meet deliverables.

  • Build effective relationships with internal and external stakeholders and provide guidance to junior QA staff.

  • Support data integrity initiatives and proactively identify opportunities for process improvement.

  • Develop expertise as a qualified trainer and act as a reviewer, approver, or change agent as required.

  • Provide support for QA review of validation activities, including VMP, PPQ, supporting studies, validation protocols/reports, and CPV.

  • Perform other duties as assigned by the supervisor.

​What we’re looking for:
  • Degree in Biological Science / Engineering and experiencein Quality unit in theBiopharmaceutical industry. 

  • 3-4 years of experiencein a similar type of industry or a similarjob role.

  • Able to operate independently with minimumsupervision.

  • Fair knowledge and experience of the practical and theoretical requirement of quality managementsystem in a GMP facility

  • Team player, with strong focus on safety, quality and 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.

 

Senior Specialist, QA (Technical Support ) · US0Lonza Biologics Inc.

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