Senior Specialist, QA (Mfg Support)

Posted 12 Days Ago
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Singapore, SGP
In-Office
Senior level
Pharmaceutical
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization.
The Role
Supports Quality Assurance operations in a GMP biopharmaceutical manufacturing facility. Responsibilities include lot disposition, product release, document review and approval, quality oversight, deviation investigations, CAPA management, manufacturing-floor guidance, compliance monitoring, audits, and continuous improvement projects. The role is fully site-based and shift-based, requiring collaboration with manufacturing and cross-functional teams to maintain product quality, safety, and regulatory compliance.
Summary Generated by Built In

 

The QA Specialist will support day-to-day Quality Assurance 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 site‑based shift role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.


The QA Senior Specialist will be required to perform shift.

 

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

  • Coordinate lot disposition and product release activities, including shipping documentation.
  • Review and approve SOPs, protocols, reports, batch records, and other quality-related documents
  • Provide Quality oversight of product status and the quality tag-out system.
  • Review and approve deviation investigations, applying Root Cause Analysis to support timely closure.
  • Oversee CAPA implementation and ensure timely and effective closure.
  • Provide real-time Quality guidance on manufacturing floor activities in accordance with GMP, SOPs, and policies.
  • Support manufacturing changeovers and day-to-day QA activities within a GMP biopharmaceutical facility.
  • Identify cGMP/GDP non-compliance and provide appropriate corrective guidance.
  • Analyze data, resolve quality issues, and recommend process improvements.
  • Participate in manufacturing walkdowns, Regulatory and Customer Audits, and related follow-up activities.
  • Lead and coordinate Quality projects and continuous improvement initiatives.
  • Provide compliance guidance and Quality support to cross-functional teams.
  • Build strong relationships with internal and external stakeholders.
  • Perform other duties as assigned by the supervisor.

 

What we’re looking for

  • Degree from a recognized institution in a relevant discipline.
  • 1–3 years of relevant experience in a similar role, preferably within a biopharmaceutical or GMP-regulated environment.
  • Relevant QA Operations experience in a biopharmaceutical manufacturing environment.
  • Hands-on experience working and collaborating with cross-functional teams on manufacturing activities.
  • Good understanding of Quality Management Systems and GMP requirements.
  • Meticulous, systematic, and detail-oriented.
  • Strong team player with a focus on safety, quality, compliance, 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.

Skills Required

  • Degree from a recognized institution in a relevant discipline
  • 1–3 years of relevant experience in a similar role
  • Relevant QA Operations experience in a biopharmaceutical manufacturing environment
  • Hands-on experience collaborating with cross-functional teams on manufacturing activities
  • Good understanding of Quality Management Systems and GMP requirements
  • Meticulous, systematic, and detail-oriented approach
  • Strong teamwork and focus on safety, quality, compliance, and timelines
  • Experience in a biopharmaceutical or GMP-regulated environment
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The Company
HQ: Basel
Year Founded: 1897

What We Do

At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.

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