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The opportunity : Consultant/ Senior Consultant-TMT-Business Consulting Risk-CNS - BC - Technology Risk - Bangalore (Remote as well)TMT : 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.We help TMT companies create compelling employee and customer experiences, retaining skills and talent while achieving enterprise-wide operational excellence. We help them guard their data, brand and reputation. We also enable the pursuit of M&A strategies that methodically 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 ResponsibilitiesExperience in Quality and Compliance with hands-on computer system validation experience for enterprise applications like SAP ECC/S4 HANA, Trackwise, LIMS, Veeva VaultExposure to validation of emerging technology like AI, RPA would be an added advantagePerform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)Create/review end to end CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reportsManage projects from a delivery perspectiveProvide guidance and oversight of validation activities for projects involving GxP relevant computer systemsWork closely with project team members to incorporate appropriate elements of quality and compliance throughout the system lifecycleExperience in FDA/EMA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validationExperience in performing assessments based on 21 CFR Part 11 and Annexure 11 requirementsTechnical Excellence Computer system validation for GxP systemsComputer system validation experience for enterprise applications like SAP ECC/S4 HANA, Trackwise, LIMS, Veeva VaultTo qualify for the role you must have Engineers. B.Tech/ BE/ B.Pharma/ M.PharmaExperience 4-11 YearsWhat 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 postivie energy, while being adaptable and creative in their approach.What We Offer With more than 200,000 clients, 300,000 people globally and 33,000 people in India, EY has become the strongest brand and the most attractive employer in our field, with market-leading growth over compete. Our people work side-by-side with market-leading entrepreneurs, game- changers, disruptors and visionaries. As an organisation, we are investing more time, technology and money, than ever before in skills and learning for our people. At EY, you will have a personalized Career Journey and also the chance to tap into the resources of our career frameworks to better know about your roles, skills and opportunities.EY is equally committed to being an inclusive employer and we strive to achieve the right balance for our people - enabling us to deliver excellent client service whilst allowing our people to build their career as well as focus on their wellbeing.If you can confidently demonstrate that you meet the criteria above, please contact us as soon as possible.Join us in building a better working world. Apply now.
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