â™¦ Reviewed and Validated Computer Systems in compliance with 21 CFR Part 11 and GxP FDA Regulations.
â™¦ Experience in generating and reviewing Computer Systems Validations
â™¦ Working knowledge of GLP, GMP, GAMP V guidelines especially in the areas of computer or related systems
â™¦ Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment,
â™¦ Decommission report, Periodic Review Report.
â™¦ Excellent Knowledge and experience in Good Documentation Practices.
â™¦ Manage security policies on QC lab systems.
â™¦ Backup of Electronic Data.
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Salary: Not Disclosed by Recruiter
Industry:IT-Software / Software Services
Functional Area:IT Software - Application Programming, Maintenance
Role Category:Programming & Design
Role:Team Lead/Technical Lead
Employment Type:Permanent Job, Full Time
Desired Candidate Profile
UG:B.Tech/B.E. - Any Specialization, Computers, Electronics/Telecommunication, BCA - Computers
PG:MCA - Computers
Doctorate:Doctorate Not Required
Recruiter Name:Ridhi Prasad
Contact Company:LUPIN LIMITED