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. Post Graduate / Graduate with relevant CSV experience