Quality Ops Specialist II: Systems & Improvements

One Stop Engineering; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

AbbVie Operations Singapore seeks a Quality Operations Specialist to ensure quality system execution across manufacturing and production areas at Tuas site. You will lead investigations, trend data, and drive kaizen for continuous improvement while ensuring released batches meet regulatory standards.

The role requires a Bachelor Degree in Sciences/Pharmacy/Engineering with 3+ years in quality/compliance (GxP), and experience with SAP or TrackWise is preferred.

Qualifications

• Bachelor Degree in sciences, pharmacy or engineering.
• Minimum 3+ years of pharmaceutical/biopharmaceutical quality/compliance (GxP) experience.
• Knowledge of quality/regulatory requirements for APIs/biologics.
• Experience with SAP or TrackWise preferred.
• Application of quality risk management.
• Strong commitment to quality and high work standards.
• Demonstrates integrity and strong work ethic.
• Good knowledge of GxP requirements and regulations.
• Strong project management, planning and scheduling skills.
• Excellent verbal and written communication.
• Good interpersonal skills and cross-functional collaboration.

Responsibilities

• Assist site management to oversee quality system execution in manufacturing areas.
• Observe, document, monitor, trend and report quality adverse events.
• Lead and champion quality system improvement projects.
• Release incoming materials, processes and product batches.
• Perform regular audits of inspection packages, batch records and manufacturing logs.
• Support Annual Product Quality Review and Product Quality Assurance.
• Perform data trending and drive kaizen in respective areas.
• Lead change management activities and cross-functional risk assessments.

Skills

Quality/compliance management

GxP knowledge

Quality risk management

Project management

Communication skills

Interpersonal skills

Education

Bachelor Degree in Sciences/Pharmacy/Engineering

Tools

SAP

TrackWise

Job description

AbbVie Operations Singapore seeks a Quality Operations Specialist to ensure quality system execution across manufacturing and production areas at Tuas site. You will lead investigations, trend data, and drive kaizen for continuous improvement while ensuring released batches meet regulatory standards.

The role requires a Bachelor Degree in Sciences/Pharmacy/Engineering with 3+ years in quality/compliance (GxP), and experience with SAP or TrackWise is preferred.