Lead / Senior Specialist, QA (External)

Lonza; Singapore; Sur place; SGD 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Comprehensive medical insurance

Company transport to Tuas site

Résumé du poste

Lonza in Singapore is seeking a QA Specialist to support day-to-day Quality Assurance activities in a fully site‑based role. You will work on deviations, change controls, CAPA plans, and document reviews to uphold cGxP standards and data integrity.

In this role, you will collaborate across functions, review quality records, and participate in regulatory inspections and audits to ensure product quality and compliance. Competitive benefits and growth opportunities are offered.

Qualifications

• Degree or higher from a recognized institution with 3–10 years’ experience in Validation / Quality unit in the Biopharmaceutical industry.
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, ICHQ7).
• Good knowledge of GMP quality management systems and data integrity practices.

Responsabilités

• Support day-to-day QA activities in compliance with SOPs and cGxP requirements.
• Review and approve SOPs, protocols, reports, and quality records.
• Lead deviation investigations, change controls, CAPA plans, and troubleshooting activities.

Connaissances

Quality Assurance

Validation

Biopharma

Formation

Bachelor's degree

Description du poste

The QA Specialist will support day-to-day Quality Assurance activities.

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 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.

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.
• Support daily QA activities in compliance with approved SOPs, policies, and cGxP requirements.
• Review and approve SOPs, protocols, reports, and quality records.
• Lead deviation investigations, change controls, CAPA plans, and troubleshooting activities.
• Ensure data integrity and drive continuous quality improvement.
• Support and lead regulatory inspections, customer audits, and audit responses.
• Perform material release, qualification, defect inspections, and review vendor investigation reports.
• Lead projects, manage deliverables, and coordinate cross-functional activities.
• Maintain strong stakeholder relationships and develop training and internal GxP auditing competencies.
• Participate in facility walkdowns and perform other duties as assigned.

What we are looking for:

• Degree or higher from recognized institution with 3 to 10 years’ experience in Validation / Quality unit in the Biopharmaceutical industry
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7).
• Good knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
• Team player who can operate independently, 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.

Reference: R80260

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.