Consultant - Digital Risk

Job Summary

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

Industry convergence offers TMT (Technology, Media & Entertainment, and Telecommunications) organizations the chance to evolve and transform, but it also presents challenges around competitiveness and delivering agile corporate strategies for growth. Content distributors are transforming into content producers, service providers are becoming tech companies, technology companies are the catalyst for dramatic change in every sector, and customers want the latest innovations now.

We help TMT companies create compelling employee and customer experiences, retaining skills and talent while achieving enterprise-wide operational excellence. We help them protect their data, brand and reputation. We also enable the pursuit of M&A strategies that systematically create value, reduce risk and transform TMT companies into powerhouses that will lead the technology revolution of the future, building a better working world for all.

Your key responsibilities Technical Excellence

• Strong capability in managing end-to-en
• Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)
• Create/ reviewCSV 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

Skills and attributes

To qualify for the role you must have

• Experience in Quality and Compliance withhands-on computer system validation experience on Enterprise Applications (SAP ECC/HANA, LIMS, QMS, ELN, DMS, PLM, CRM, CTMS, RPA etc.)
• Experience in FDA regulated environment 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