Computer System Validation Consultant

4 - 8 years

6 - 10 Lacs

Posted:1 week ago| Platform: Naukri logo

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Work from Office

Job Type

Full Time

Job Description

Responsibilities-

1. Expertise in computer system validation, QMS and IT Compliance.

2. Good understanding of GAMP 5, 21 CFR Part 11, Annex 11, ICH Q9.

3. Validation experience and expertise in manufacturing, QC and enterprise systems.

4. QMS: Initiation/Review of change management, Investigation, CAPA, Deviation etc.

5. Review the IT activities- Backup report, user access management, Support in internal audit and IT Compliance management.

6. The candidate should have experience in SOP preparation and review.

7. Project and stakeholder management.

8. Periodic review and IT schedule activity management

9. Excellent verbal and written communication skills.

Note: This is 6 days working. Month's first Saturday will be off. And transportation services will be provided.

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Infocus Technologies

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