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IT Compliance Manager
2 months ago
Key Responsibilities
- Support the headquarters IT team in the design and deployment of information systems such as MES, LIMS, and QMS at the facility.
- Possess a solid understanding of GMP principles, enabling effective risk management during project execution and the formulation of appropriate risk mitigation strategies.
- Accountable for drafting standard operating procedures, protocols, and compliance documentation for the IT division in alignment with FDA regulations.
- Oversee the routine operation, troubleshooting, and upkeep of GMP-compliant information systems to guarantee their functionality and data accuracy.
- Engage in the testing, validation, and refinement phases of computerized systems prior to their operational launch.
- Work collaboratively with various departments, including business and quality assurance, to address quality incidents and deliver technical assistance.
- Assist with activities related to system validation.
- Offer insightful technical recommendations and solutions aimed at enhancing systems and processes.
- Champion technological advancements and system enhancements.
- Coordinate with other technical teams, business units, and management to comprehend and fulfill the broader organizational requirements.
Required Qualifications
- A minimum of 5 years of IT experience within the pharmaceutical sector.
- Familiarity with FDA regulations concerning data integrity and governance of computerized systems.
- Knowledge of FDA compliance standards, with the ability to manage changes, deviations, CAPA (Corrective and Preventive Actions), and related activities.
- Capability to conduct GMP audits for both internal and external evaluations, with a solid understanding of relevant processes and biopharmaceutical regulatory standards.
- Expertise in 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, along with hands-on experience in implementation, validation, and operational support.
- Experience in the administration and maintenance of servers, networks, and computers, with practical skills in at least one area such as database administration, development, mainstream network engineering, or infrastructure. Proficient in working and communicating in a global business context.