Job Title:  Manager | CSV | Mumbai | SAP

• 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

Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential.

The Team

The team 
 Enterprise technology has to do much more than keep the wheels turning; it is the engine that drives functional excellence and the enabler of innovation and long-term growth. Learn more about ET&P 

Work you’ll do

The primary role is to make immediate, direct contributions to enhancing our clients’ competitive position and performance in ways that are distinctive, innovative, and sustainable.

To do this, one must perform the following activities within the firm:

SAP CSV Professional should have: (10 to 12 Yrs)

      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 16 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​ 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.

Personal attributes

• Communication: Excellent written and oral communication skills; able to engage with multiple levels of the organization
• Dealing with Ambiguity: Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; remains calm, effective and practical when dealing with ambiguity; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty
• Self Confidence

·      Good interpersonal skills

·      Ability to collaborate and communicate with stakeholders and external parties.

·      Excellent communication skills - written and oral in English

• Large degree of flexibility and the ability to work under strong time pressure
• Inspire and motivate team.

Qualifications

• Graduate degree (Science or Engineering) from premier institutes.
• Strong communication skills (written & verbal).
• Willingness to travel for short- and long-term durations.

Your role as a leader

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.

• Actively focuses on developing effective communication and relationship-building skills
• Builds own understanding of our purpose and values; explores opportunities for impact
• Understands expectations and demonstrates personal accountability for keeping performance on track
• Understands how their daily work contributes to the priorities of the team and the business
• Demonstrates strong commitment to personal learning and development; acts as a brand ambassador to help attract top talent

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. Explore Deloitte University, The Leadership Centre

Benefits

At Deloitte, we know that great people make a great organization. We value our people and offer employees a broad range of benefits. Learn more about what working at Deloitte can mean for you.

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. Learn more about Deloitte's impact on the world