Job Description

What impact will you make Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you\'ll find unrivaled opportunities to succeed and realize your full potential The Team Deloitte helps organizations prevent cyberattacks and protect valuable assets. We believe in being secure, vigilant, and resilient-not only by looking at how to prevent and respond to attacks, but at how to manage cyber risk in a way that allows you to unleash new opportunities. Embed cyber risk at the start of strategy development for more effective management of information and technology risks. Work you\'ll do As a part of our Risk Advisory team you\'ll build and nurture positive working relationships with teams and clients with the intention to exceed client expectations. You\'ll: Key Responsibilities: Define Validation strategy of IT Software and Systems Actively participate in the Validation Life Cycle of regulated IT projects or platforms by planning validation deliverables, working on validation documentation, participating in authoring deliverables, functional requirements definition, traceability matrix, validation protocol development, Validation testing and deviation management and working closely with cross-functional project teams. Reduce risk of compliance by taking proactive actions Ensure 21 CFR Part 11 compliance for Computerized system Provide User training on CSV and increase awareness about compliance Responsible for reducing Gaps identified in various GAP/Risk Assessments existing and new computerized system and provide remedial action plan for compliance. Carrying out Audit of IT systems to ensure regulatory compliance Resolve conflicting end - user requirements Manage the specified business / systems requirements, working closely with the designated Project Manager to facilitate progress of the project Coach / mentor staff and provide technical leadership, as needed The key skills required are as follows: IT Quality, Regulatory, Compliance (IT-QRC) Quality guidelines mentioned by FDA, MHRA and other regulatory bodies GxP practices and GAMP5 guidelines Computer System Validation of various COTS products like COGNOS, IMPACT, BAELN and other related applications used in pharmaceutical industries Experience in activities like Business Analysis, Risk Identification, FRS creation and other validation testing deliverables. Good understanding & practical experience of 21CFR Part 11 and other FDA GxP regulations An understanding of current industry techniques for requirements elicitation, analysis, and specification Experience in performing initial assessments of QSIA/GxP Assessment, Validation Scalability Evaluation to determine the GxP relevance and scope of validation based on GAMP 5 categorization of system/software.Risk Advisory Cyber Risk - Computer System Validation Qualifications:- B.E./B.Tech./MCA/MBA/M.Sc/B.Pharm/M.Pharm Professional Qualification - Computer System Validation Experience 12+ Years Your role At Deloitte India, we believe in the importance of leadership at all levels. We expect our people to embrace and live our purpose by challenging themselves to identify issues that are most important for our clients, our people, and for society and make an impact that matters. In addition to living our purpose, across our organization: Builds own understanding of our purpose and values explores opportunities for impact Demonstrates strong commitment to personal learning and development acts as a brand ambassador to help attract top talent Understands expectations and demonstrates personal accountability for keeping performance on track Actively focuses on developing effective communication and relationship-building skills Understands how their daily work contributes to the priorities of the team and the business How you\'ll grow At Deloitte, our professional development plan focuses on helping people at every level of their career to identify and use their strengths to do their best work every day. From entry-level employees to senior leaders, we believe there\'s always room to learn. We offer opportunities to help build world-class skills in addition to hands-on experience in the global, fast-changing business world. From on-the-job learning experiences to formal development programs at Deloitte University, our professionals have a variety of opportunities to continue to grow throughout their career. Benefits At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Our purpose Deloitte is led by a purpose: To make an impact that matters . Every day, Deloitte people are making a real impact in the places they live and work. We pride ourselves on doing not only what is good for clients, but also what is good for our people and the communities in which we live and work-always striving to be an organization that is held up as a role model of quality, integrity, and positive change.

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