QA Quality Check

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company based in Singapore is seeking a Quality Assurance Specialist to monitor compliance within their QC laboratory. Candidates should have a relevant degree and at least 5 years experience in a GMP-regulated lab. Responsibilities include reviewing test results, preparing for audits, and leading investigations into quality challenges. Strong communication skills and proficiency in quality management systems are essential for this role. This position offers a chance to drive quality outcomes in a dynamic environment.

Qualifications

• Bachelor’s degree or higher in a related scientific discipline.
• Minimum 5 years of experience in QA or QC role within a GMP-regulated laboratory.
• Strong hands-on experience in biological, microbiological or chemical testing.

Responsibilities

• Monitor and ensure quality compliance within the QC laboratory.
• Review and approve laboratory test results and analytical procedures.
• Prepare for and support internal and external audits.

Skills

Quality Assurance

Quality Control

Communication Skills

Problem Solving

Leadership

Education

Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmacy or related discipline

Tools

Quality management software

LIMS

Job description

Monitor and ensure quality compliance within the QC laboratory, ensuring all activities fully adhere to GMP and applicable regulatory requirements.

Review and approve laboratory test results, analytical procedures and related documentation to ensure completeness, accuracy and compliance with relevant regulations such as FDA, EMA, ISO and other industry standards.

Prepare for and support internal and external audits and regulatory inspections, ensuring full compliance with all regulatory expectations and company policies.

Proactively identify potential risks within testing processes and laboratory operations, leading investigations and implementing effective corrective and preventive actions (CAPA) to maintain consistent compliance and quality standards.

Oversee method validation activities, ensuring appropriate validation of laboratory test methods—including biological, microbiological and receptor-based assays—in alignment with regulatory requirements and industry best practices.

Drive continuous improvement initiatives across laboratory testing processes, equipment and systems to enhance operational efficiency, data integrity, accuracy and overall quality outcomes.

Collaborate closely with cross‑functional teams to resolve quality‑related issues and support smooth and compliant laboratory and business operations.

Requirements

1. Bachelor’s degree or higher in Chemistry, Biochemistry, Biology, Pharmacy or a related scientific discipline.
2. Minimum 5 years of experience in a Quality Assurance (QA) or Quality Control (QC) role within a GMP‑regulated pharmaceutical laboratory.
3. Strong hands‑on experience in biological, microbiological or chemical testing within the pharmaceutical or biotechnology industry.
4. Comprehensive understanding of FDA, EMA and other applicable regulatory requirements.
   Familiar with sterile pharmaceutical manufacturing and quality systems.
5. Experience with ADC manufacturing is highly preferred.
6. Excellent communication skills (verbal and written), with the ability to interact effectively with cross‑functional stakeholders.
7. Proven ability to lead investigations and address complex quality challenges in a regulated environment.
8. Proficient in quality management software, LIMS and other laboratory information systems for documentation, tracking and data management.