Job Title:  Consultant | CSV | Hyderabad | SAP | DSA LS&HC

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Deloitte.

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Consultant | SAP CSV | Hyderabad | SAP

• Job requisition ID: 107611
• Location: Hyderabad
• Entity: Deloitte Touche Tohmatsu India LLP

The team

Enterprise technology must 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

Your work profile

• 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 7 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.

Key skills requiredE

RONAL ATTRIBUT

• Communication: Excellent written and oral communication skills; able to engage with multiple levels of the organization

• Should have at least 7 years of experience in quality assurance and/or computerized system validation processes in a regulated environment in life sciences and healthcare (LSHC) industry.

• Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11 etc..)

• 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

You bring you

That's all we ask. And in return, we'll create an enabling and respectful environment. That includes reasonable accommodation for Fate unique needs.

Your bold odyssey starts here 

Our story starts with your success: Experience excellence in an environment that is meritorious, respectful, collaborative, and empowering. One that is a catalyst of 360-degree happiness for you and your loved ones.

Get right skilled for tomorrow: Get equipped to fuel transformative change and be the best in the industry. Don't just learn new skills, but be the engine of innovation, with clutter-breaking solutions and practices.

Power the nation's growth story: We're Indian-owned and led and working towards India's future. Our team spans and creates impact for the country, well beyond its urban centers. We move ahead along with the communities in which we operate, thereby giving you a profession with a strong sense of purpose.