CSV Consultant job - Chennai,Tamil Nadu,India - Multi Recruit

Not Specified

View Applications

Chennai,Tamil Nadu,India

Skills

Computer System Validation CSV Consultant Validation Process 21CFR 11

Experience: 4 to 10 Years
Industry: 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:2

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

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