Responsibilities
- Assist HQ-IT in the construction and implementation of information systems (MES, LIMS, QMS) at the site.
- Have a good understanding of GMP awareness, be able to control related risks involved in project implementation, and develop corresponding risk response measures.
- Responsible for creating standard operation procedures, protocols, and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements.
- Responsible for the daily operation, troubleshooting, and maintenance of GMP-related information systems to ensure their normal operation and data integrity.
- Participate in the testing, validation, and optimization iterations of computerized systems before they go live.
- Collaborate with departments such as business and QA in handling quality incidents and providing technical support.
- Support tasks related to system validation.
- Provide constructive technical advice and solutions to improve systems and processes.
- Drive technical innovation and system optimization.
- Collaborate with other technical departments, business units, and management to understand and meet the overall company needs.
Qualifications
- 5 years of IT-related work experience in the pharmaceutical industry.
- Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems.
- Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks.
- Possesses the ability to conduct GMP audits for both internal and external purposes, familiar with related processes and biopharmaceutical regulatory guidelines.
- Knowledgeable about QMS (Quality Management System), DMS (Document Management System), MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), and WMS (Warehouse Management System) related information systems, with practical experience in implementation, validation, and operational maintenance.
- Have experience in the management and maintenance of servers, networks, and computers, with technical practice in at least one area such as DBA, development, mainstream network engineering, and infrastructure.
- Ability to work and communicate in a global business environment.
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