USI-EH26-Consulting-RRF-RRF Operate-CSV-Associate Solution Advisor

Regulatory, Risk & Forensic

Our Regulatory, Risk & Forensic team supports client leaders to translate multifaceted risk and an evolving regulatory environment into defensible actions that help strengthen, protect, and transform organizations. Join our team and use advanced data, AI and emerging technologies with industry insights to help client service teams bring clarity from complexity and accelerate their path to value creation.

Position Summary

Level: Consultant

As an experienced Consultant at Deloitte Consulting Services, you will be responsible for individually delivering high quality work products within due timelines. Need-basis you will be mentoring and/or directing junior team members/liaising with onsite/offshore teams to understand the functional requirements.

Work you’ll do:

Our Regulatory, Risk & Forensic Operate professionals help organizations effectively navigate business risks and opportunities—from strategic, reputation, and financial risks to operational and regulatory risks—to 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:

• 2.5 - 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:

• BE/B. Tech/M.C.A./M. Sc (CS) degree or equivalent from accredited university

Location:

• Bengaluru/Hyderabad/Pune/Chennai/Kolkata