Manager DI & CSV

Job description

• Ensure all the computerized systems meeting the 21 CFR Part 11, EU ANNEX 11and GAMP5 guidelines requirements.
• Perform, review approve computerized system validation life cycle deliverables.
• Responsible for implementation and compliance of data integrity at site as DICO (Data Integrity Compliance officer).
• Implement regimen of Data integrity checks on shopfloor and updating of Data Integrity Risk Assessment (DIRA).
• Responsible for handling and compliance of SOPs related to Data Integrity IT systems.
• Review / conduct of investigations related to Data integrity, Computerized Systems, and engineering department as applicable.
• Coordination for data integrity and IT-systems projects with stakeholders at site and corporate as well.
• Handling Participation in internal Data Integrity audits, its compliance.
• Involve in selection of Data Integrity (DI) champions Impart necessary trainings to the DI champions
• Review of Change controls, Deviations, CAPA and other QMS tools.
• Review of Periodic review reports.
• Participated in supplier assessment for Computerized Systems, instruments equipments etc.
• Review approve the schedules of data back-up restoration, time synchronization etc.
• Audit trail reports review of computerized systems i.e. HMI, SCADA, DCS, etc.
• Review and ensure the compliance of user management activities of Computerized Systems.
• Preparation / review of the quality risk assessments i.e. part 11 compliance, data integrity etc.
• Review the Qualification documents of the manufacturing equipments, facility, utilities and associated ancillary systems.
• CAPA effectiveness verification.
• GMP compliance verification for the manufacturing equipment area, utilities and testing instruments.
• Review of software application qualifications.
• Comply with SHE Guidelines, SHE Rules and Regulations. Comply with usage of PPE wherever applicable.
• Observe unsafe acts and conditions and take corrective preventive actions immediately, as necessary.
• Report any incident/accident/near miss/illness to the superiors.
• Follow companys quality procedures, standards, and specifications.