- Senior
- Optionales Büro in Goa
Job Description
1.Supervise compliance to all cGMP, GxP, or any other regulatory requirements, including EH&S requirements.
2. To execute & close QAMS tasks related to CCP, CAPA and deviations related to IT department.
3. Complete self-training and monitor training of team members on the relevant SOPs.
4. Execute and supervise all tasks and activities as per the applicable SOPs.
5. Responsible to ensure overall IT compliance.
6. To coordinate with technical training as a "Departmental Training Coordinator" to meet required training compliance of the department.
7. Responsible to complete the assigned trainings, applicable for workgroup “IT-Personnel-GOA” in the L2LMS (SABA).
8. To perform administrative related activities for QC instrument systems.
9. Responsible for Request and review Backup Schedule, Revision, Archival, folder lock/unlock and Data restoration activity.
10. To provide server administrative support during installations, upgradations, breakdowns and maintenance.
11.To perform user administration activities for QAMS and CDAS.
12.To perform audit trail review of Elogbook and QAMS.
13. Responsible to Handling and compliant implementation of IT Policies and procedures associated for GxP computerized systems.
14. Support site on regulatory audits and prepare necessary mitigation plans.
15. Responsible to prepare self-inspection compliance report.
16. Responsible to perform Departmental Representative activities for Kavach.
17. Responsible to ensure implementation of corrective and preventive actions within timeline.
18. Encourage a culture of quality compliance and open communication that supports all employees to raise quality concerns or suggest improvements.
19. To provide support to project team members for New IT Infra rollout, network support in implementation.
Work Experience
5 to 7 years
