Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

1.Prepare and review all CSV documents related to software/application.

2.Develop and execute validation documents (Validation Plan, System requirement specification, Risk Assessment Installation Qualification, Operational Qualification and Performance Qualification etc.)

3.Author key validation deliverables like Validation Plan, Test Plans, Summary Reports, etc.

4.To perform GxP analysis and Gap assessment and its mitigation actions.

5.IT QMS handling, CAPA deviation and Change Control management, handle administration of site-specific applications in QC, Manufacturing and Engineering.

6.Ensure the execution of all processes complies with various worldwide regulations

i.e. GAMP 5, 21CFR part 11, EU Annexure 11.

7.Assist in 21 CFR Part 11 Assessment.