The Data Integrity Compliance Officer ensures that the QC Laboratories and Manufacturing Operations have awareness of Data Integrity as it relates to paper and electronic records. He or she ensures good documentation practices for electronic and paper based data and set the standards for them within the site. The Data Integrity Compliance Specialist is proficient in the application of 21CFR Part 11 and Annex 11 regulations as well as stays current with updates to these regulations, including WHO annex 5, MHRA.
He or she leads a multidisciplinary team of laboratory, operations, compliance, validation, quality, and engineering personnel
• Establishes and chairs the Data Integrity Italian Governance Team meetings.
• Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 requirements.
• Provides assessments and status updates to aid Data Integrity Governance team’s actions to maintain and proactively improve data integrity.
• Performs risk assessments to determine high risk equipment and audit trails and takes appropriate action to bring into compliance. Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase.
• Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices.
• Creates/updates procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations. Routinely evaluates regulatory inspection documents and updates site procedures accordingly. Keeps the Governance Team aware of industry trends.
• Establishes and leads a Surveillance program to audit all GMP facilities within the site for compliance to establish documentation and data integrity standards, practices, and procedures.
Education And Experience
- At least 2/3 years of experience in CSV for Manufacturing area and QC; knowledge of following (preferred) systems SCADA, MES, LIMS, EMS, BMS, OSI-PI;
- Experience in validating automation systems with following technology (i.e. IFIX platform, Batch Systems, Historian, Simatic Batch)
- Knowledge of GAMP 5, Annex 11, MHRA, WHO annex 5
- Knowledge of IT Infrastructure
- Experience in Data Integrity Program within multisite company environment
- English language