Job Summary

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

Your key responsibilities

- 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 workplace with good 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.
- To qualify for the role you must have a graduate degree from a reputed University.
- 3 - 13 years of overall CSV experience.
- Hands on experience of 21 CFR/ CSV.
- Ideally you ll also have Excellent written and verbal communication, interpersonal, networking, teaming and problem-solving skills.
- Be highly flexible, adaptable, and creative.
- Initiative in keeping abreast of changing industry practices, analysis and design methods, tools and techniques and emerging technologies.
- Willingness to work in different time-zones as required.
- What we look for: Highly motivated, you will be a good communicator with the ability to contribute confidently to technical security discussions with peers and management. You will be a team player who is not only looking to enhance their own career, but recognises the value in working well with others and the value of teamwork.

Qualifications

- Bachelor of Technology in Computer Science
- b.pharmacy

Experience

- CSV experience 2-12 years

Disclaimer: This job posting and location 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.

📌 Associate Consultant - Business Consulting Risk - TMT - CNS - RISK (Bengaluru)
🏢 EY
📍 Bengaluru