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.