Larsen & Toubro Infotech Ltd Looking for Senior Specialist – Quality Engineering at[...]

Larsen & Toubro Infotech Ltd; Kolkata; On-site; INR 6,75,000 - 9,00,000; Full time

Job summary

An established industry player is seeking a seasoned professional in Computer System Validation to ensure compliance with regulatory standards. This role involves creating validation plans, executing test protocols, and collaborating with teams to uphold quality assurance practices. The ideal candidate will have extensive experience in supporting validation work, particularly with Veeva Quality Vaults, and possess strong problem-solving and communication skills. Join a dynamic team where your expertise will contribute to maintaining high-quality standards in a fast-paced environment, making a significant impact on the organization's success.

Qualifications

• 10+ years of experience in Computer System Validation.
• Hands-on experience with quality assurance and control principles.

Responsibilities

• Create and review validation plans and reports for compliance.
• Execute test protocols and review test scripts for accuracy.

Skills

Computer System Validation

Quality Assurance

Quality Control Principles

Effective Communication Skills

Problem-Solving Skills

Team Collaboration

Tools

Veeva Quality Vaults

Job description

Job Description

Responsibilities including, but not limited to:

1. Create a validation plan/test plan using a risk-based approach.
2. Create a validation report that verifies compliance to the plan.
3. Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable.
4. Review executed operational, performance qualification documents for verifying that the testing effort has been completed, defects captured, objective evidence attached.
5. Write, review, evaluate the configuration management plans and procedures associated with the development process.
6. Verify that requirements can be traced through design, code, and test phases as applicable, creating Traceability Matrix.
7. Raise a CR with proper description, reason for change, implementation plan, impact assessment and other requirements per Ultragenyx SOP; Review and verify execution of CR; Monitor CR through closure.
8. Dry run and execute test protocols. Review executed test scripts.

Technical Requirements & Skills:

1. 10 years of relevant experience.
2. Hands-on experience of supporting Computer System Validation.
3. Experience with industry-standard and best practices regarding quality, quality assurance and quality control principles and techniques (e.g., 21 CFR Part 11, GAMP 5).
4. Knowledge of GxP best practices, international standards to quality management and methodology.
5. Experience supporting computer system validation work related to Veeva Quality Vaults (Quality Docs & Quality Management System) – Required.
6. Proven experience collaborating with others, including employees and contractors.
7. Effective communication skills (written and oral).
8. Effective and independent problem-solving skills.
9. Great team player.