SalaryNot Specified
Job Location Chennai,Tamil Nadu,India


Computer System Validation CSV Consultant Validation Process 21CFR 11
4 to 10 Years
IT - Software Services
Functional Area
Software Development - System Programming
Job Title / Designation: CSV Consultant

Job Responsibilities:

  • Responsible for theory and content of validation documents and reports for software validation, changes, on-going review, and revalidation, as requested by the client
  • Establish cost-efficient and time-efficient methods of performing Computer System Validation activities as well as Data Integrity initiatives.
  • Responsible for creation, execution and review of validation packages as per Clients requirements.
  • Lead system qualification efforts and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply.
  • Ensure system qualification/validation documentation is in compliance with Client policies and procedures, as well as meet regulatory requirements.
  • Responsible for providing training to client SMEs on best practices as well as building a robust Computer System Validation and Data Integrity Culture within Clients organization.
  • Ensure System Backup and System Audit Trail Verification tests are conducted as per clients guidelines
  • Execute Data Integrity protocol and Electronic Records and Signatures Assessment
  • Assist other team members in creation, review andimplementation of Standard Operating Procedures required for maintaining system validated state.
  • Single point of Accountability for specific Computer System Validation Project.
  • For Manufacturing CSV Expert specifically, must possess knowledge of system alarms and recipes; and have experience in both Software Validation as well as integrated equipment-software qualification tests to demonstrate robustness of controls in place.
  • For Laboratory CSV Expert specifically, must possess prior experience in validating standalone laboratory systems.
  • For Empower 3 CSV Expert specifically, must possess prior experience and knowledge in validation and implementation of Empower 3 across the network, custom field creation and validation, and training module creation and implementation.
  • Must maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).
  • Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.

Minimum/Maximum/ Work Experience Required: 4-10 Years

Annual CTC: Not a Constraint

Location(s) of Job: Chennai

Minimum Education Requirements: BS Degree; Computer Science preferred

No of rounds of Interviews:

Work Timings: 8 AM 5 PM; 6 days per week

Hindi; English (Mandatory); Additional languages (Tamil/Telugu) preferred as well

Multi Recruit
Multi Recruit
Bangalore, Basavangudi
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