Officer

Job Description

1. xecute and supervise all tasks and activities as per the applicable SOPs
2. Ensuring compliance and Implementation of all SOPs including Corporate, Site Specific.
3. Ensure Computer System Software Validation and Maintaining Validated status of all Computerize System Software as per SOPs in line with cGMP guidelines
4. Identifying GAPs in current practice and plan mitigation for each GAP as per agreed time-line
5. Prepare comprehensive support matrix to support day-to-day functions.
6. Maintain control to ensure that all team members are trained on the relevant SOPs and support continuous learning/ capability building.
7. Encourage a culture of quality compliance and open communication that supports all employees to raise quality concerns or suggest improvements.
8. User management execution and data management as a site IT administrator
9. Periodical Audit Trail Review as per SOP and participating in various internal/External audits.
10. User management of computerized software system for QC and manufacturing systems.
11. Managing the Backup, Restoration and archival as per SOPs
12. Prepare and participate in management review to provide status on various on-going projects progress, compliance status and related actionable.
13. Carry out periodical audit to access the IT system and give effective solutions if any discrepancy found. Also handle escalations and downtime and ensure change control process
14. Work on avenues of Cost optimization without loss critical business requirement.
15. Manage IT engineers and Support vendor hence responsible for managing operations/Manufacturing systems/QC systems.
16. Monitor and raise Short term and Long-term planning for Location IT Manpower
17. To provide support to project team members for New IT Infra rollout, network support in implementation.
18. Manage and ensure information technology computer systems at Site by planning, development, organizing, controlling and evaluating IT policies, standards, procedures and electronic data operations.
19. Ensure required security controls and safe IT working to be established in the environment.
20. Ensure and facilitate the Backup, Restore & Archive of all electronic data.
21. User Management of computerized systems in accordance with the applicable SOPs.
22. Vendor Coordination, Asset Management. Review the IT asset data; ensure physical assets and their system records.

Work Experience

7-10 Years

Education

Competencies