1. Assist in establishing the company's electronic data integrity and computerized system management system;

2. Maintain and improve the existing data integrity (DI) quality system, identify and evaluate risks related to electronic data, and propose corresponding risk mitigation measures;

3. Supervise IT to carry out computerized system security management (such as physical security and logical security), IT infrastructure management and compliance management (such as computerized system supplier management, time synchronization management, electronic data and audit trail audit management, system retirement, authority configuration, GMP electronic account management, etc.);

4. Participate in IT electronic data management, such as data archiving, data migration, data security, and disaster recovery management (BCP) system management, to ensure that data reliability management meets regulatory requirements, optimize electronic data audit processes, and improve audit efficiency and quality;

5. Be responsible for compliance construction and management of electronic data audit, and provide technical support and professional consultation for the team in electronic data management and audit.

6. Be responsible for auditing the accuracy and completeness of electronic data, and auditing the audit trail to ensure that the data meets the standards of the company and industry;

7. According to the requirements of domestic and international data reliability management and quality management, guide all business departments to check the compliance of the company's public systems, production equipment, experimental equipment, records and data (including but not limited to audit trail and data consistency);

8. Regularly organize compliance spot checks on the experimental process and records of production and experimental personnel;

9. Write the data audit report, record and track the problems found in the audit process and improvement measures, and maintain relevant documents.

10. Complete other tasks assigned by the leaders.

1. Bachelor degree or above, major in pharmaceutical engineering, bioengineering and other related fields;

2. More than three years of experience in electronic data auditing of public systems, production equipment (fermentation, ultrafiltration, purification equipment, etc.) and inspection instruments in aseptic drugs or biological products enterprises;

3. Understand the computerized systems of pharmaceutical factories (EMS, QMS, DMS, LIMS, TMS, etc.);

4. Understand GMP, GAMP5 and DI and other relevant laws and regulations, and be familiar with the regulatory requirements and guiding principles of the pharmaceutical industry, as well as relevant technical standards and quality management requirements;

5. Have SOP drafting experience and be familiar with ICH, ISPE, PIC/S, WHO, FDA, EU and other relevant laws and regulations;

6. Those with experience in change, deviation, CAPA follow-up processing are preferred;

7. Good computer operation skills, familiar with CSV are preferred;

8. Familiar with production or analytical equipment audit tracking requirements are preferred;

9. Experience in official audit work such as GMP, NMPA, FDA, etc. is preferred.