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 potentialThe TeamDeloitte 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 doAs 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:The key job responsibilities include the following:

• 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
• 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
• 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\xe2\x80\x8b 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.

How you\'ll growAt 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-levelemployees 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.BenefitsAt Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits.Our purposeDeloitte 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.

Deloitte