Deloitte—Senior Consultant | CSV | Hyderabad | SAP | DSA LS&HC

Job description

Description: Senior Consultant | CSV | Hyderabad | SAP | DSA LS&HC • Job requisition ID : 111881 • 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 Experienced Computer System Validation (CSV) professional with experience in Life Sciences and Healthcare (LSHC) environments. Responsible for planning, executing, and maintaining validation activities for GxP-regulated computerized systems. Expertise in regulatory compliance including GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11. Key skills required · Should have at least 8 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..) - 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 AI/ML validationn - 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