Urgent Opening-for Dy. Manager-IT QA

Urgent Opening-for Dy. Manager-IT QA

Urgent Opening @ Hyderabad

Position: Dy. Manager-IT QA

for Reputed API Pharma company

Should be Msc/MPharma with Minimum Should be 8-10 years of experience in API Pharma Manufacturing companies only
Handling Projects like – QMS, DMS, LIMS, Empower Software, Standalone
Applications, etc…
2. Handling Internal, External Auditors like (USFDA, ANVISA, EDQM, TGA, Client audits,
3. Coordinate, handle and manage Internal/External audits, certification audits or
inspections and ensuring accuracy, availability of information during these audits.
4. Participates in the development of IT policies and procedures.
5. Maintaining Compliance as per Regulatory Requirement across locations.
6. Plant IT Infrastructure documents preparations.
7. Verifying backup data by restoring as per predefined SOP schedule.
8. Computer System Validation for GxP Computers and Servers across locations.
9. Systems Audit Trail review for GxP Computerized systems and servers.
10. Handling Quality Management System (Change Control’s, Deviation, Risk
assessments, CAPA and Investigations) related to IT.
11. Conducting In-House audits in IT department and ensure that locations -IT
department are fully complied as per GxP.
12. Conducting review meetings and reporting the same on timely manner.
13. Training to the team on Compliance, regulatory and Industry practices
14. Knowledge on Data center, Servers, and Virtual environments

interested pls share your profile to
email: [email protected]