IT Compliance Manager
1 week ago
Key Responsibilities
- Support the headquarters IT team in the design and execution of information systems such as MES, LIMS, and QMS at the facility.
- Possess a solid understanding of Good Manufacturing Practices (GMP) and manage associated risks during project execution, developing 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-related information systems to guarantee their functionality and data integrity.
- Engage in the testing, validation, and enhancement phases of computerized systems prior to their deployment.
- Work collaboratively with various departments, including business and Quality Assurance, to address quality incidents and deliver technical assistance.
- Assist with system validation activities.
- Offer insightful technical recommendations and solutions to enhance systems and workflows.
- Promote technological advancements and system improvements.
- Coordinate with other technical divisions, business units, and leadership to comprehend and fulfill the overall organizational requirements.
Required Qualifications
- A minimum of 5 years of IT experience within the pharmaceutical sector.
- Familiarity with FDA regulations regarding data integrity and governance for computerized systems.
- Knowledge of FDA regulatory standards, with the ability to manage changes, deviations, and CAPA (Corrective and Preventive Actions).
- Capability to conduct GMP audits for both internal and external purposes, with familiarity in related processes and biopharmaceutical regulatory standards.
- Understanding of QMS (Quality Management System), DMS (Document Management System), MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), and WMS (Warehouse Management System) information systems, with hands-on experience in implementation, validation, and operational support.
- Experience in managing and maintaining servers, networks, and computers, with technical expertise in at least one area such as database administration, development, mainstream network engineering, or infrastructure. Ability to communicate effectively in a global business context.
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