BriefCase
BriefCase

Computer Validation Engineer Job in Sage It

Computer Validation Engineer

Sage It 4+ weeks ago
Apply Now
Job Summary
  • 6+ years of experience in CSV Implementation with MES/ SCADA experience
  • Ensure compliance to industry standards like GAMP5, FDA 21 CFR Part 11 on electronic records, electronic signatures etc.
  • Define Risk based strategies for validation of computerized systems and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan
  • Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
  • Draft SOPs, writing scripts for IQ, OQ, PQ and handling CSV
  • Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
  • Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel
  • Experience in Internal Audit, External Audit. Face regulatory, customer, IT Quality System related inspections for all computerized systems
  • Responsible for review & verification of Corrective Action Plan for audits
  • Perform periodic review/monitoring of computer systems implemented
  • Proven experience in developing Master Validation Plan, validation scripts, Validation reports, all documentations required during CSV Implementation Process
Experience Required :

6 to 12 Years

Vacancy :

2 - 4 Hires

Similar Jobs for you

See more recommended jobs