Site-Based Stability QC Lead (GMP)

Lonza; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Daily company bus from MRT to Tuas

Fully paid medical insurance

Dependent coverage option

Job summary

Lonza Lead Specialist, Quality Control (Stability) is a site‑based role in Singapore. You will lead protocols for stability studies, coordinate stability programs, and ensure compliance and data integrity across audits and regulatory requirements.

The role requires a strong background in GMP environments and collaboration across cross‑functional teams. You will be responsible for stabil ity chamber maintenance, data analysis, and driving continuous improvement while upholding Lonza’s standards.

Qualifications

• Degree or higher in Life Sciences/Pharmaceuticals.
• 5+ years in quality or manufacturing operations in GMP/FDA/EMEA regulated pharma env.
• Knowledge of regulatory requirements (FDA/EMEA).
• Strong GMP validation experience.

Responsibilities

• Lead and author protocols and reports for stability studies and investigations.
• Support stability programs including pulls, shipments, and LIMS setup.
• Collaborate with cross-functional teams to resolve communication, compliance and documentation issues.
• Provide timely project updates to stakeholders.
• Manage preventive maintenance and requalification of stability chambers and equipment.
• Troubleshoot equipment/method issues with data mining and trend analysis.
• Handle multiple priorities ensuring timely, compliant delivery.
• Contribute to Annual Product Reviews and regulatory documents.
• Drive operational efficiency and continuous improvement initiatives.
• Participate in internal/external audits as required.

Skills

Quality control

Project management

Data integrity

Regulatory awareness

Education

Life Sciences/Pharmaceuticals degree

Tools

Stability LIMS

GMP validation

Validation programs

Job description

Lonza Lead Specialist, Quality Control (Stability) is a site‑based role in Singapore. You will lead protocols for stability studies, coordinate stability programs, and ensure compliance and data integrity across audits and regulatory requirements.

The role requires a strong background in GMP environments and collaboration across cross‑functional teams. You will be responsible for stabil ity chamber maintenance, data analysis, and driving continuous improvement while upholding Lonza’s standards.