CSV IT Engineer

jOB Discription

Compliance:

1. Ensure The compliance to CGMP, GxP, or any other regulatory Requirements (GAMP5, 21CFR Part 11, EU Annexure 11,ICH Q9, ISO27001).

2. Ensure Compliance and implementation of all IT and CSV and Compliance SOPs.

3. Ensure Computerized System Validation (CSV) and maintaining validate state of all computerized system as per defined Sops.

4. Maintain control to ensure that all team members are trained on the relevant sops.

5. Effective management of Change control process and deviation.

6. Periodic Review of validation documents as per their periodic review schedule as participate internal audit, identifying Gaps in the current practices and plan mitigation for each gap.

7. Provide training on IT SOPs, CSV Sops and Change control process to relevant stockholders.

8. Encourage a culture of quality Compliance and open communication that supports all employees to raise quality concern and suggest improvements.

Information Technology (IT)

1. Ensure the GXP Application in operation and maintenance phase of different domains (Pre-clinical, Clinical) through the change control.

2. Handling the Scada application system, Quality Control system troubleshooting of Application Like HPLC, GC, Empower, TOC, Thermo Lab Stability Control system, Labsolution, Polarimeter, Tiamo, Autoclave, Open lab GC, Water System.

3. Handling IT infrastructure Project handling day to day activity.

4. Responsible for daily Data Backup as per compliance and maintaining records. And responsible for Monthly data Backup Activity.

5. Responsible for server installation and Configuration and Qualification Activities.

6. Responsible for software installation and Qualification Responsible for server heath checkup and maintenance.