Project QA Scientist

WuXi AppTec; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

WuXi AppTec is seeking a QA reviewer to support technology transfer and batch record review in Singapore. You will ensure quality requirements are met, documents comply with GMP and regulatory standards, and support timely product release.

The role requires bilingual fluency in Chinese and English, strong analytical thinking, and effective cross-department collaboration to drive issue resolution and audit readiness.

Qualifications

• Degree or higher in Organic Chemistry, Pharmaceutical Engineering or related field.
• Fresh graduates welcome.
• Experience with GMP and pharmaceutical regulations preferred.
• Fluent in Chinese and English for bilingual communication and report writing.
• Strong analytical and investigative reporting skills.
• Excellent cross-functional collaboration abilities.

Responsibilities

• Participate in tech transfer document review to ensure quality.
• Review master batch records for compliance with policies.
• Execute batch record review for production accuracy.
• Review quality standards and analytical methods for validity.
• Review validation documents to ensure regulatory compliance.
• Lead change control and deviation investigations.
• Ensure timely product release by enforcing quality standards.
• Prepare documentation and host customer audits.
• Coordinate onsite audit activities and respond to inquiries.
• Attend customer meetings to communicate quality matters.
• Review deviation/investigation reports with clear conclusions.

Skills

Communication skills

Analytical thinking

Problem solving

Teamwork

Bilingual Chinese/English

Education

Bachelor's degree in Organic Chemistry or Pharmaceutical Engineering

Job description

• Participate in the review of technical documents related to technology transfer, ensuring the transfer process meets quality requirements and is implemented smoothly.
• Responsible for master batch record review to ensure related documents, processes, and procedures comply with company policies and regulatory requirements.
• Execute batch record review, verifying production records for completeness, accuracy, and compliance.
• Review quality standards and analytical methods to ensure their scientific validity and compliance with regulatory requirements.
• Review process validation master plans (VMP), validation protocols, and validation reports to ensure validation activities comply with company and regulatory standards.
• Lead change control and deviation management related to projects, driving deviation investigations, corrective actions, and preventive measures.
• Responsible for product release, strictly controlling quality standards to ensure timely release of compliant products.
• Host customer audits by preparing relevant documentation, coordinating onsite audit activities, and responding to audit inquiries to ensure successful audit outcomes.
• Attend customer meetings to communicate project quality matters promptly, provide feedback on issues and improvements, and maintain good customer relationships.
• Review deviation and investigation reports, ensuring reports are logically structured, data is detailed, and conclusions are clear.

Qualifications:

• Degree or above in Organic Chemistry, Pharmaceutical Engineering, or related fields. Fresh graduate are welcome to apply
• Relevant work experience is preferred; familiarity with pharmaceutical manufacturing and quality management regulations (e.g., GMP) is essential.
• Fluent in both Chinese and English, capable of professional bilingual communication and report writing.
• Clear thinking and rigorous logical reasoning skills, with proficiency in problem analysis and investigation report writing.
• Strong communication and coordination skills, capable of effectively collaborating across departments to drive issue resolution.
• Strong sense of responsibility, attention to detail, and good team spirit.