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.
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.
