Computerized System Validation

Found in: Talent IN C2 - 3 weeks ago

Baddi, India INSTRUMENTATION AND CONTROL SOLUTIONS Full time

Hiring a Computer System Validation Engineer.

Location: Baddi (H.P.)

Salary- Depend on Interview

JD-

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 the 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.

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