Job Summary

The opportunity: Senior Consultant-TMT-Business Consulting Risk-CNS - RISK - DIGITAL RISK - Bangalore

Responsibilities

Technical Excellence

- Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)
- Create/review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports
- Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
- Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle
- Review and approve computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables
- Experience in Quality and Compliance with hands-on computer system validation experience on Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS etc.)
- Experience in FDA regulated environment with positive understanding of cGxP (cGMP, cGDP, cGAMP, cGLP)



standards and Risk based validation.
- Experience with validation/ testing tools like HPALM, Azure DevOps (ADO) etc. will be an added advantage.
- Experience in training validation resources will be an added advantage.

Qualifications

- Bachelor of Technology in Computer Science
- phamracy

Experience

- csv 2 to 13 years

Competencies

What we look for

People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements. You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions. We look for people who are agile, curious, mindful, and able to sustain positive energy, while being adaptable and creative in their approach.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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