Senior QA Lot-Release Specialist — GMP Operations

Lonza; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading global biotechnology company in Singapore is seeking a Quality Assurance professional to oversee day-to-day operations at a GMP facility. You will ensure compliance by reviewing and approving various documents and lead quality control initiatives. The ideal candidate holds a Bachelor's degree in a related field, has over 5 years of QA experience, and is well-versed in regulatory guidelines. This role offers an inclusive corporate culture, competitive compensation, and extensive benefits.

Benefits

Compensation that recognizes high performance

Daily company bus from MRT

Fully paid medical insurance

Qualifications

• 5+ years of QA experience in GMP biopharma or similar regulated environment.
• Working knowledge of FDA, EMA, and ICH Q7 guidelines.
• Proven experience with deviations, CAPAs, and change control.

Responsibilities

• Perform day-to-day QA oversight in a multi-product GMP facility.
• Review and approve SOPs, protocols, reports, batch records and batch disposition.
• Lead or participate in deviations, change controls, and CAPAs.

Skills

Quality Assurance oversight

Risk-based decision-making

Strong communication

Collaboration across functions

Organizational skills

Education

Bachelor’s degree in Chemical, Biomedical, or related Engineering

Job description

A leading global biotechnology company in Singapore is seeking a Quality Assurance professional to oversee day-to-day operations at a GMP facility. You will ensure compliance by reviewing and approving various documents and lead quality control initiatives. The ideal candidate holds a Bachelor's degree in a related field, has over 5 years of QA experience, and is well-versed in regulatory guidelines. This role offers an inclusive corporate culture, competitive compensation, and extensive benefits.