T&T - Cyber - Validation - AM - Pune

Your potential, unleashed.

India s impact on the global economy has increased at an exponential rate and Deloitte presents an opportunity to unleash and realise your potential amongst cutting edge leaders, and organisations shaping the future of the region, and indeed, the world beyond.

At Deloitte, your whole self to work, every day. Combine that with our drive to propel with purpose and you have the perfect playground to collaborate, innovate, grow, and make an impact that matters.

The team

Risk Advisory is about much more than just the numbers. It s about attesting to accomplishments and challenges and helping to assure strong foundations for future aspirations. Deloitte exemplifies the what, how, and why of change so you re always ready to act ahead. Learn more about Risk Advisory Practice

Your work profile

As an Assistant Manager in our Extended Enterprise Team you ll build and nurture positive working relationships with teams and clients with the intention to exceed client expectations: -

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:

Role Description -

• Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11 etc..)
• Participate as a Validation Subject Matter Expert to support the development of business requirements documentation, technical designs, test strategy and plans, etc.
• Responsible to set up the validation strategy to ensure agility & speed in delivery
• Should be able to defined and execute end to end validation activities for IT projects and system releases/upgrades
• Build effective working relationships and collaborate with other domain and enterprise resources to ensure system validation needs are being met.
• Should be able to create and review applicable validation deliverables such as GxP Assessment, Validation Plan, URS, FRS, DS, Configuration Specification, IQ , OQ , PQ test plan , test report , Validation Summary Report etc.
• Should have experience in performing Data Migration for validated systems.
• Exposure to cloud validation , Supplier assessment.
• Exposure to Infrastructure Qualification for GxP relevant systems.
• Periodic Reviews of the IT Systems including user reviews and maintaining the validated state of the IT System
• Deviation Handling - RCA using 5 x Why approach or any similar approach and CAPA
• Experience in handle Change Request during operational phase.
• Requirement Risk Assessment , IT Risk Assessments and Data Privacy related tasks
• Support Supplier Assessments and provide guidance.
• End to end validation activities for IT projects and system releases/upgrades
• Define test strategy and review test cases in accordance with test plan.
• Support in Internal audit and inspections
• Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
• Perform validation functional testing as required. Track and resolve deviations during qualification activities.
• Test Strategy Definition: Creating a comprehensive testing strategy, including test plans and test data plans across all phases of the SDLC.

Desired qualifications

• Minimum of 5 years of relevant work experience as a Computer System Validation Professional, including hands-on experience with domain systems (Enterprise Level Application i.e., ERP, MRP, QMS, LIMS, etc.) in support of global business operations
• Regulatory Knowledge and Experience: Proficient in regulatory requirements such as GMP, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11, etc.
• Validation Subject Matter Expert: Capable of supporting the development of business requirements documentation, technical designs, test strategies, and plans.
• Validation Strategy: Responsible for setting up validation strategies to ensure agility and speed in delivery.
• End-to-End Validation: Skilled in defining and executing end-to-end validation activities for IT projects and system releases/upgrades.
• Collaboration: Ability to build effective working relationships and collaborate with other domain and enterprise resources to meet system validation needs.
• Validation Deliverables: Proficient in creating and reviewing validation deliverables such as GxP Assessment, Validation Plan, URS, FRS, DS, Configuration Specification, IQ, OQ, PQ test plans, test reports, and Validation Summary Reports.
• Data Migration: Experienced in performing data migration for validated systems.
• Cloud Validation and Supplier Assessment: Exposure to cloud validation and supplier assessment.
• Infrastructure Qualification: Experience in infrastructure qualification for GxP relevant systems.
• Periodic Reviews: Conduct periodic reviews of IT systems, including user reviews, to maintain the validated state of the IT system.
• Deviation Handling: Skilled in handling deviations using RCA (Root Cause Analysis) with approaches like 5 Whys and CAPA (Corrective and Preventive Actions).
• Change Request Management: Experienced in handling change requests during the operational phase.
• Risk Assessments: Proficient in requirement risk assessment, IT risk assessments, and data privacy-related tasks.
• Supplier Assessments: Support supplier assessments and provide guidance.
• Test Strategy and Case Review: Define test strategies and review test cases in accordance with the test plan.
• Internal Audits and Inspections: Support internal audits and inspections.
• Project Participation: Participate in project teams, assist in determining project schedules, and appropriate levels of validation.
• Validation Functional Testing: Perform validation functional testing as required, track, and resolve deviations during qualification activities.
• Test Strategy Definition: Create comprehensive testing strategies, including test plans and test data plans across all phases of the SDLC (Software Development Life Cycle).

Location and way of working

• Base location: Pune
• This profile involves frequent / occasional travelling to client locations OR this profile does not involve extensive travel for work.
• Hybrid is our default way of working. Each domain has customized the hybrid approach to their unique needs.

Your role as an Assistant Manager

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.

In addition to living our purpose, Senior Executive across our organization must strive to be:

• Inspiring - Leading with integrity to build inclusion and motivation
• Committed to creating purpose - Creating a sense of vision and purpose
• Agile - Achieving high-quality results through collaboration and Team unity
• Skilled at building diverse capability - Developing diverse capabilities for the future
• Persuasive / Influencing - Persuading and influencing stakeholders
• Collaborating - Partnering to build new solutions
• Delivering value - Showing commercial acumen
• Committed to expanding business - Leveraging new business opportunities
• Analytical Acumen - Leveraging data to recommend impactful approach and solutions through the power of analysis and visualization
• Effective communication - Must be well abled to have well-structured and well-articulated conversations to achieve win-win possibilities
• Engagement Management / Delivery Excellence - Effectively managing engagement(s) to ensure timely and proactive execution as well as course correction for

the success of engagement(s)

• Managing change - Responding to changing environment with resilience
• Managing Quality & Risk - Delivering high quality results and mitigating risks with utmost integrity and precision
• Strategic Thinking & Problem Solving -