IT Compliance Senior Specialist

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 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.
• 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.
• 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.