Quality Compliance & Audit Specialist II

AbbVie Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

AbbVie Pte Ltd in Singapore is seeking a Quality Compliance Specialist to support site quality programs and ensure adherence to cGMP and regulatory requirements. You will participate in audits, inspections, regulatory submissions, and data governance activities to maintain compliance across manufacturing operations.

The role emphasizes collaboration with cross-functional teams, risk management, and continuous improvement in quality systems, with a focus on product quality, patient safety, and

Qualifications

• 2–5 years in a cGMP regulated environment.
• 2+ years in compliance and audit preferred.
• Experience in audit management, product review, and quality metrics preferred.
• Knowledge of ICH, CFR, Eudralex, PIC/S guidelines preferred.
• Strong communication and interpersonal skills required.

Responsibilities

• Support site quality compliance programs to ensure cGMP adherence.
• Assist in internal audits and external inspection management.
• Support regulatory submissions and site master file maintenance.
• Coordinate data governance activities and data integrity training.
• Assist in quality metrics and risk management activities.
• Support product complaints and recall management.

Skills

cGMP compliance

Audit management

Regulatory standards

Communication

Data governance

Problem solving

Education

Bachelor's/Master's in Sciences/Pharmacy/Engineering

Job description

AbbVie Pte Ltd in Singapore is seeking a Quality Compliance Specialist to support site quality programs and ensure adherence to cGMP and regulatory requirements. You will participate in audits, inspections, regulatory submissions, and data governance activities to maintain compliance across manufacturing operations.

The role emphasizes collaboration with cross-functional teams, risk management, and continuous improvement in quality systems, with a focus on product quality, patient safety, and