Quality Specialist (QA/QC)

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

Location: Singapore

The Quality Specialist supports the implementation and maintenance of GMP-compliant quality systems for Moleac's outsourced manufacturing network. The role provides quality control and quality assurance oversight of contract manufacturing organizations (CMOs), testing laboratories, and suppliers, ensuring that raw materials, intermediates, and finished products meet established specifications and regulatory requirements.

The position supports batch release activities through review of manufacturing and analytical documentation, management of quality records, and coordination with external partners.

ESSENTIAL DUTIES & RESPONSIBILITIES

1. GMP Quality Oversight

• Provide QA oversight of contract manufacturers, testing laboratories, and suppliers to ensure compliance with current Good Manufacturing Practices (cGMP).
• Maintain and organize GMP documentation including specifications, test methods, batch records, and quality reports.
• Support maintenance of the company's Quality Management System (QMS), including SOPs and controlled documents.
• Ensure proper documentation practices and compliance with GMP and Good Distribution Practice (GDP) requirements.
• Support internal preparation for regulatory inspections and GMP audits.
• Assist in compilation of Product Quality Reviews (PQR/APQR).

2. Batch Release Documentation & QC Review

• Review manufacturing batch records, packaging records, and Certificates of Analysis (CoA) from contract manufacturers and testing reports from testing laboratories.
• Verify that manufacturing and testing activities comply with approved specifications, validated/approved methods, and regulatory filings.
• Perform QC release for packaging materials and raw materials.
• Maintain batch release trackers and ensure completeness of required quality documentation.
• Review analytical test results and stability data for compliance with product specifications.

3. Analytical & Stability Program Oversight

• Track analytical testing activities performed by contract laboratories for raw materials, intermediates, and finished products.
• Maintain QC trackers and testing schedules to ensure timely completion of required analyses.
• Support management of stability programs, including monitoring of stability study schedules and review of stability data.
• Assist in trending analytical results and identifying potential quality trends or deviations.

4. Quality Event Management

• Track and support investigations related to deviations, Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, and product complaints reported by contract manufacturers or laboratories.
• Support documentation and follow-up of corrective and preventive actions (CAPA).
• Maintain logs and trackers for deviations, investigations, and quality events.
• Assist with evaluation of potential quality impacts to released or in-process batches.
• Support investigation for customer complaint.

5. Change Control & Supplier Quality

• Support assessment and tracking of manufacturing, analytical, or supplier changes through the company's change control process.
• Assist in maintaining supplier and contract manufacturer qualification documentation.
• Support maintenance of quality agreements with external partners.
• Track implementation of changes affecting manufacturing processes, testing methods, or product specifications.

6. Production & Supply Coordination

• Coordinate with contract manufacturers on sample testing schedules and documentation requirements.
• Maintain internal trackers for production batches, testing status, and product release timelines.
• Support coordination with supply chain teams to ensure proper handling and documentation of incoming and outgoing materials.

Qualifications

• Diploma or Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or a related discipline.
• 2-5 years of experience in pharmaceutical, biotech, or GMP-regulated environments.
• Familiarity with cGMP, pharmaceutical quality systems, and regulatory requirements.
• Experience working with contract manufacturers in China and Singapore or testing laboratories is advantageous.
• Strong attention to detail and ability to manage technical documentation.
• Strong coordination and communication skills for working with external partners and internal stakeholders.
• Good written and verbal communication skills. (This role requires liaising with suppliers/manufacturers in China).

Key Competencies

• GMP documentation and compliance awareness
• Analytical data review and quality assessment
• Quality system coordination (deviations, CAPA, change control)
• Cross-functional coordination with CMOs and supply chain teams
• Strong organizational and documentation management skills