1. Responsibilities
1. Responsible for creating standard operation procedures, protocols and compliance related documents for IT department in accordance with FDA regulatory and compliance requirements.
2. Responsible for the daily operation, troubleshooting, and maintenance of GMP-related information systems to ensure their normal operation and data integrity.
3. Work with user department on daily maintenance and provide support on equipment / instruments and associated system.
4. Participate in the testing, validation, and optimization iterations of computerized systems before they go live.
5. Collaborate with departments such as business and QA in handling quality incidents and providing technical support.
6. Support tasks related to system validation.
2. Qualifications
1. 9 years( above) of pharmaceutical industry experience, specifically around IT audit, compliance, and IT operations.
2. Be familiar with FDA regulatory requirements on data integrity and data governance on computerized systems.
3. Familiar with FDA regulatory standards, possessing the capability to handle changes, deviations, CAPA (Corrective and Preventive Actions), and similar tasks.
4. Possesses the ability to conduct GMP audits for both internal and external purposes, familiar with related processes and biopharmaceutical regulatory guidelines.
5. 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.
6. Controls experience with systems development life cycle, access management, computer operations, networking, and security
7. Knowledgeable in information security and IT operations (including complex legacy infrastructure/application environments within the manufacturing industry)
8. Skilled in creating documentation, sharing technical information, and training less experienced team members.
9. Ability to work and communicate in a global business environment.