Project QA Engineer

Key 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. Qualifications: • Master’s degree or above in Organic Chemistry, Pharmaceutical Engineering, or related fields.Fresh graduate are welcome. • 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.