USI-EH26-Consulting-RRF-RRF Operate-CSV-Analyst

Job Description Summary Position Summary Regulatory, Risk & Forensic Our Regulatory, Risk & Forensic team supports client leaders to translate multifaceted risk and an evolving regulatory environment into defensible actions that strengthen, protect, and transform organizations. Leverage advanced data, AI, and emerging technologies with deep domain and industry insights to help bring clarity from complexity and accelerate the path to value creation. P osition Summary Level: Analyst As an experienced Analyst at Deloitte Consulting Services , you will be responsible for individually delivering high quality work products within due timelines. Work you'll do: Our Regulatory, Risk & Forensic Operate professionals help organizations effectively navigate business risks and opportunitiesfrom strategic, reputation, and financial risks to operational and regulatory risksto gain competitive advantage. We apply our experience in ongoing business operations and corporate lifecycle events to help clients become stronger and more resilient. Our market-leading teams help clients embrace complexity to accelerate performance, disrupt through innovation, and lead in their industries. We support clients by delivering Operate services spanning the Regulatory, Risk & Forensic portfolio. We embed continuous advantage through domain, industry, technology / Gen AI, and transformation skills to perform client business functions that manage risk and deliver value - added outcomes. The team: Deloitte's Life Sciences IT Quality practice is targeted at life sciences companies combining the competencies of regulatory compliance, technology, operations and automation to help organizations address challenges in an integrated, targeted, and cost-effective manner. Deloitte provides customized solutions with process-driven frameworks backed with automation for clients to achieve their strategic objectives in multiple areas including computerized system validation services (CSV), pharmacovigilance, etc. Work you will do Being part of our team, you are responsible for all the aspects of development, execution, and maintenance pertaining to Digital Quality. You will work with clients and engagement teams to help them establish documented evidence that meets regulatory compliance standards by authoring/reviewing deliverables required for regulatory compliance/submission. This is a high visibility role and will drive cross functional collaboration that requires you to provide expertise on Part 11 compliance of ERP systems, Digital Health, R&D systems, regulatory submission systems and other boundary systems/tools, governance, control and execution of people and process, etc. Qualifications Must Have Skills/Project Experience /Certifications : - 1 .5 - 2.5 years of experience in the pharma or medical device industry with a focus on quality and regulatory compliance. - Experience in systems validation and quality framework . - Hands on knowledge of software lifecycle approaches (GAMP5, Agile, Waterfall) . - Hands on project management skills managing medium to large projects with end-to-end validation experience . - Clear understanding of principles, procedures and governance of validation activities Good to Have Skills/Project Experience/Certifications : - Identify and manage regulatory risks to support clients in regulatory compliance, governance and controls. - Coordinate with cross-functional project teams for new application development and other validation projects to include reviews, risk analysis and other QA activities in support of systems development. - Assist clients in developing strategies for process improvement which caters to the needs of the quality organization . - Author validation strategies and other plans/protocols and summary reports (end-to-end computerized system validation experience is mandatory. - Coordinate and interface with R&D, Engineering, Software Development, IT, Manufacturing and Quality Assurance groups to assure successful project execution and end-user training . - Plan, manage and execute as needed, installation, operational and performance qualifications in accordance with current Good Manufacturing Practices ( cGMPs ) - Review and approve validation lifecycle documentation . - Provide Quality review and assessment of associated change requests related to processes, IT infrastructure and computer systems. - Manage project governance, including providing progress updates of the assigned deliverables, driving timely closures of escalations and facilitating strategic decisions with senior management. Education: - B.E / B. Tech /M.C.A./ M.Sc (CS) degree or equivalent from accredited university Location: - Bengaluru/Hyderabad/Pune/Chennai//Kolkata Our purpose Deloitte's purpose is to make an impact that matters for our people, clients, and communities. At Deloitte, purpose is synonymous with how we work every day. It defines who we are. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities. Our people and culture Our inclusive culture empowers our people to be who they are, contribute their unique perspectives, and make a difference individually and collectively. It enables us to leverage different ideas and perspectives, and bring more creativity and innovation to help solve our clients most complex challenges. This makes Deloitte one of the most rewarding places to work. Professional development At Deloitte, professionals have the opportunity to work with some of the best and discover what works best for them. Here, we prioritize professional growth, offering diverse learning and networking opportunities to help accelerate careers and enhance leadership skills. Our state-of-the-art DU: The Leadership Center in India, located in Hyderabad, represents a tangible symbol of our commitment to the holistic growth and development of our people. Explore DU: The Leadership Center in India . Benefits To Help You Thrive At Deloitte, we know that great people make a great organization. Our comprehensive rewards program helps us deliver a distinctly Deloitte experience that helps that empowers our professionals to thrive mentally, physically, and financiallyand live their purpose. To support our professionals and their loved ones, we offer a broad range of benefits. Eligibility requirements may be based on role, tenure, type of employment and/ or other criteria. Learn more about what working at Deloitte can mean for you. Recruiting tips From developing a stand out resume to putting your best foot forward in the interview, we want you to feel prepared and confident as you explore opportunities at Deloitte. Check out recruiting tips from Deloitte recruiters. Requisition code: 306434