QA Specialist

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 50,000 - 90,000; Full time

Job summary

A leading company in biologics manufacturing is seeking a proactive Manufacturing QA Specialist or Senior Specialist to ensure compliance with GMP standards. This position involves overseeing testing activities, managing quality systems, and supporting site startup operations. Ideal candidates will have extensive QA/QC experience in a production environment and a degree in a relevant field.

Qualifications

• Bachelor's degree in a relevant field is required.
• QA/QC experience with specifics for Specialist (3-5 years) or Senior Specialist (8-10+ years).
• Familiar with global GMP standards and quality system development.

Responsibilities

• Ensure GMP production and testing compliance with regulatory standards.
• Provide QA oversight for validation and qualification activities.
• Lead quality event management, including deviations and audits.

Skills

Problem-solving

Communication

Ownership mindset

Education

Bachelor’s degree or above in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering

Tools

Microsoft Office

Job description

Manufacturing QA Specialist / Senior Specialist

Job Summary

We are seeking proactive and detail-oriented individuals to join our Manufacturing Quality Assurance (MQA) team. You will oversee GMP manufacturing and testing activities, ensuring compliance with internal procedures and regulatory expectations. Based on your experience, you will take on responsibilities ranging from operational execution to strategic quality oversight.

Key Responsibilities

• Ensure on-site GMP production and testing activities comply with internal procedures and global regulatory standards (FDA, EMA, PICS).

• Contribute to the development and implementation of an effective quality system.

• Provide QA oversight for validation, qualification, and requalification activities.

• Review and approve manufacturing/testing-related documents and batch records.

• Authorize the release of facilities, utilities, and equipment for production use.

• Lead or support the management of quality events: deviations, change controls, CAPA, lab investigations.

• Assist with internal and external audits and inspections.

• Support cross-functional collaboration to maintain compliance and operational efficiency.

Qualifications

• Bachelor’s degree or above in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or related fields.

• For Specialist level: 3–5 years of QA/QC experience, with at least 3 years in production QA.

• For Senior Specialist level: 8–10+ years of QA/QC experience, with at least 8 years in production QA.

• Experience in biologics manufacturing and commercial supply; ADC experience is a plus for senior-level candidates.

• Familiar with global GMP standards and regulatory requirements.

• Prior experience supporting new site startup is a plus.

• Strong communication, problem-solving, and ownership mindset.

• Proficient in Microsoft Office and fluent in English.