Digital - IT / Senior Executive Curateq Biologics

5.0 - 10.0 years

8 - 15 Lacs

Hyderabad

Work from Office

Role & responsibilities 1. Responsible for Digital compliance with respect to computerized systems and Application software. 2. Manage and execution of the activities such as Data Backup, Archival, Restore, Time synchronization / harmonization of computer systems, equipments and instruments and User access management at site. 3. Support in Computerized System Qualification and Validation activities. 4. Support to vendor in Equipment or Instrument Installation activity. 5. To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 6. Prepare and update of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 7. Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 8. Ensure that the computerized system inventory is updated, and GxP risk classification/ Impact Assessment is performed for new or modified systems. 9. Execution of qualification documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 10. Review the user access request form for GxP computerized systems, application software and update the Authorized List of Users as per the Access Management of GxP Computerized Systems. 11. Execution of the audit trail at site as per the Review of audit trail SOP with reference to the Audit trail review schedule. 12. Prepare Periodic Review schedules and perform reviews of computerized systems and handle deviations and CAPA, if any. 13. Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. 14. Initiation of change management, deviation management and CAPA related to computerized systems activities followed by tracking for closure. 15. Involvement of self-inspection activities as per the schedule given. 16. Support regulatory inspection and quality audits, inspection readiness and qualification of service providers and preparation of audit responses with respect to computerized systems compliance. 17. To follow safety, Health and Environment norms and adhere to the company policy. Preferred candidate profile

Posted 2 days ago

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