Quality Operations Lead: GxP & Process Improvement

ONE STOP ENGINEERING PTE. LTD.; Singapore; On-site; SGD 60,000 - 110,000; Full time

Job summary

AbbVie Operations Singapore is seeking a Quality Operations Specialist to oversee the quality system execution in manufacturing and production areas. The role requires monitoring, documenting, and reporting quality events and leading improvement projects to ensure released batches meet high quality and compliance standards.

Responsibilities include overseeing incoming materials, process and product release, QA hold/tag-out administration, and data trending for continuous improvement.

Qualifications

• Bachelor degree in Sciences (Biology, Chemistry), Pharmacy or Engineering.
• Knowledge of quality/compliance management and regulations affecting APIs/Biologics.
• Experience in GxP environments and quality investigations.
• Strong project management, planning and scheduling skills.

Responsibilities

• Assist site management to oversee quality system execution in manufacturing and production areas.
• Lead investigations arising from non-compliance in incoming materials, processes or products.
• Perform data trending and drive Kaizen for continuous improvement.
• Release batches and review QA documentation (material, process, product).
• Conduct audits of inspection packages, batch records, logs and changes.
• Support new product introductions and change management activities.

Skills

Quality management

Regulatory compliance

Quality risk management

Project management

Planning and scheduling

Communication skills

Cross-functional teamwork

Attention to detail

Process improvement

Education

Bachelor's degree in science/engineering

Tools

SAP

TrackWise

Job description

AbbVie Operations Singapore is seeking a Quality Operations Specialist to oversee the quality system execution in manufacturing and production areas. The role requires monitoring, documenting, and reporting quality events and leading improvement projects to ensure released batches meet high quality and compliance standards.

Responsibilities include overseeing incoming materials, process and product release, QA hold/tag-out administration, and data trending for continuous improvement.