Scientist I, Project QA

Working Location: Tuas, Singapore

Responsibilities:

• 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.
• Perform any other ad hoc duties as required by the Department.
• Responsible for other tasks temporarily assigned.

Qualifications:

• Master’s degree or above in Organic Chemistry, Pharmaceutical Engineering, or related fields. Fresh graduates are welcome to apply
• Relevant work experience is preferred; familiarity with pharmaceutical manufacturing and quality management regulations (e.g., GMP) is essential.
• 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.
• Fluent in both Chinese and English, capable of professional bilingual communication and report writing.