Job Description:

- Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable
- Review executed operational performance qualification documents for verifying that the testing effort has been completed defects captured objective evidence attached
- Write review evaluate the configuration management plans and procedures associated with the development process
- Verify that requirements can be traced through design code and test phases as applicable creating Traceability Matrix
- Raising a CR with proper description reason for change implementation plan impact assessment and other requirements per customers SOP Reviewing and verify execution of CR Monitoring CR through closure
- Monitoring deviations and CAPAs for extension amendment approval and closure
- Conduct postimplementation periodic review of systems
- Dry run and execute test protocols Review executed test scripts
- 3-5 years of relevant experience
- Hand on experience of supporting Computer System Validation
- Experience with industrystandard and best practices regarding quality quality assurance and quality control principles and techniques eg 21 CFR Part 11 GAMP 5
- Knowledge of GxP best practices international standards to quality management and methodology
- Proven experience collaborating with others including employees and contractors
- Effective communication skills written and oral
- Effective and independent problemsolving skills
- Great team player

Skills:

Mandatory Skills :



Regulatory & Compliance - Computer system validation

About Company:

LTM is an AI-centric global technology services company and the Business Creativity partner to the world’s largest and most disruptive enterprises. We bring human insights and intelligent systems together to help clients create greater value at the intersection of technology and domain expertise. Our capabilities span integrated operations, transformation, and business AI — enabling new ways of working, new productivity paradigms, and recent roads to value. Together with over 87,000 employees across 40 countries and our global network of partners, LTM — a Larsen & Toubro company — owns business outcomes for our clients, helping them not just outperform the market, but to Outcreate it. Please also note that neither LTM nor any of its authorized recruitment agencies/partners charge any candidate registration fee or any other fees from talent (candidates) towards appearing for an interview or securing employment/internship. Candidates shall be solely responsible for verifying the credentials of any agency/consultant that claims to be working with LTM for recruitment. Please note that anyone who relies on the representations made by fraudulent employment agencies does so at their own risk, and LTM disclaims any liability in case of loss or damage suffered as a consequence of the same. Recruitment Fraud Alert - https://www.ltm.com/careers/recruitment-fraud-alert

📌 Senior Consultant (Bengaluru)
🏢 LTM
📍 Bengaluru