GMP Quality & Batch Release Specialist

MOLEAC PTE. LTD.; Singapore; On-site; SGD 67,000 - 100,000; Full time

Job summary

MOLEAC PTE. LTD. is seeking a Quality Specialist in Singapore to oversee GMP-compliant quality systems across outsourced manufacturing, testing labs, and suppliers. You will ensure raw materials, intermediates, and finished products meet regulatory specs and contribute to batch release reviews and quality record management.

The role requires experience with cGMP, QMS maintenance, and coordination with external partners to support regulatory inspections and CAPA activities.

Qualifications

• Diploma or Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or related field.
• 2–5 years in pharmaceutical, biotech, or GMP-regulated environments.
• Familiarity with cGMP, quality systems and regulatory requirements.
• Experience with CMOs in China or Singapore is advantageous.

Responsibilities

• QA oversight of CMOs, labs, and suppliers to ensure cGMP compliance.
• Review batch records, CoA and test reports for compliance with specs.
• Support QMS maintenance, SOPs, and controlled documents.
• Support regulatory inspections and GMP audits preparation.
• Review stability data and analytical results for product specs.
• Track deviations, CAPA, investigations, and quality events.

Skills

QA oversight

GMP knowledge

Documentation

Change control

CAPA

QC review

Coordination

Regulatory readiness

Education

Diploma or Degree in Pharmaceutical Sciences/chemistry/biotech

Job description

MOLEAC PTE. LTD. is seeking a Quality Specialist in Singapore to oversee GMP-compliant quality systems across outsourced manufacturing, testing labs, and suppliers. You will ensure raw materials, intermediates, and finished products meet regulatory specs and contribute to batch release reviews and quality record management.

The role requires experience with cGMP, QMS maintenance, and coordination with external partners to support regulatory inspections and CAPA activities.