Lead / Senior Specialist, QA (External)

Lonza Biologics Tuas Pte Ltd; Singapore; In loco; Riservato; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Company transport from MRT to Tuas

Career growth opportunities

Global exposure

Inclusive, ethical workplace

Descrizione del lavoro

Lonza Biologics Tuas Pte Ltd in Singapore is seeking a QA Specialist to support daily QA activities in a fully site-based role. You will review SOPs, change controls, and quality records, and lead deviation investigations with cross-functional teams to maintain data integrity and regulatory readiness.

You will contribute to continuous quality improvements, support inspections and audits, and participate in facility walkthroughs while collaborating with global teams on quality initiatives and

Competenze

• Degree or higher in a life sciences field with 3–10 years in Validation/Quality in biopharma.
• Knowledge of regulatory requirements and local codes (FDA/EMEA/ICH Q7).
• Understanding of GMP quality systems and data integrity.

Mansioni

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

Conoscenze

Quality assurance

Regulatory readiness

Data integrity

Cross-functional collaboration

Audits

Formazione

Bachelor's degree or higher in a life sciences field

Descrizione del lavoro

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.

• Access to Lonza’s full suite of employee benefits: www.lonza.com/careers/benefits

What you will do:

• 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.