Quality Assurance & GMP Operations Specialist

Nusantara Prime Consulting Pte. Ltd.; Singapore; On-site; SGD 67,000 - 89,000; Full time

Job summary

Nusantara Prime Consulting Pte. Ltd. is seeking a Quality Operations Specialist to support site management in executing the quality system across manufacturing and production areas.

This role focuses on observing, documenting, and reporting quality events to ensure highest quality and compliance of released batches. Responsibilities include reviewing materials, batch records and logs, releasing batches, and participating in investigations and change management to maintain GxP compliance.

Qualifications

• Diploma in Science, Engineering, Pharmacy or related field.
• Minimum 3 years of pharmaceutical/biopharmaceutical quality/compliance (GxP) experience.
• Experience with SAP or TrackWise preferred.

Responsibilities

• Ensure products meet policies, processes and procedures.
• Provide quality oversight of GMP manufacturing and related activities.
• Review incoming material packages, batch records, manufacturing logs and QA logs.
• Release batches and participate in investigations arising from non-compliance.
• Support change management and QA oversight activities.
• Conduct regular walk-throughs of facilities to ensure ongoing compliance.
• Assist with new product introduction and operation excellence projects.

Skills

Communication skills

Planning skills

Integrity

Quality mindset

Education

Diploma in Science or related fields

Diploma in Pharmacy

Tools

SAP

TrackWise

Job description

Nusantara Prime Consulting Pte. Ltd. is seeking a Quality Operations Specialist to support site management in executing the quality system across manufacturing and production areas.

This role focuses on observing, documenting, and reporting quality events to ensure highest quality and compliance of released batches. Responsibilities include reviewing materials, batch records and logs, releasing batches, and participating in investigations and change management to maintain GxP compliance.