Consultant - Business (Life Sciences/Healthcare)

Job Description:What are we looking forAnalysts Consultants Senior ConsultantsWe are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellenceOur analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skillsWe are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation Risk Management and Audits2 14 years of professional experience in Life Sciences industry working for a consulting services organization and or industry experienceUnderstanding of key pharmaceutical compliance regulations like Computerized System Validation 21 CFR part 11 GxP GAMP 5 SOX IT Data Privacy Data Integrity and Information SecuritySubject matter expertise in areas such as Quality Management document management and Change ManagementEstablish implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirementsKnowledge of Risk management perform root cause analysis on trends and address deviations via preventive detective and corrective measuresExperienced in Validation of SAP S4 HANA projectsKnowledge and hands on experience conducting periodic or control maturity assessment and AuditsKnowledge of various Validation tools and templates used throughout the Pharmaceutical industrySuccessful track record using Lean Agile approaches to validate assetsProven ability in handling multiple large projects respond quickly to changing situations in complex environmentsPreferable IT background to understand larger impact of architecture technical complexities on the programExperienced in leading strategic and tactical discussions with Senior stakeholdersMBA and or Advanced degree MS MPH PharmD and or PhD is preferredKey Responsibilities:What are we looking forAnalysts Consultants Senior ConsultantsWe are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellenceOur analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skillsWe are looking for people who have demonstrated proven success in roles and through abilities in Computerized System Validation Risk Management and Audits2 14 years of professional experience in Life Sciences industry working for a consulting services organization and or industry experienceUnderstanding of key pharmaceutical compliance regulations like Computerized System Validation 21 CFR part 11 GxP GAMP 5 SOX IT Data Privacy Data Integrity and Information SecuritySubject matter expertise in areas such as Quality Management document management and Change ManagementEstablish implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirementsKnowledge of Risk management perform root cause analysis on trends and address deviations via preventive detective and corrective measuresExperienced in Validation of SAP S4 HANA projectsKnowledge and hands on experience conducting periodic or control maturity assessment and AuditsKnowledge of various Validation tools and templates used throughout the Pharmaceutical industrySuccessful track record using Lean Agile approaches to validate assetsProven ability in handling multiple large projects respond quickly to changing situations in complex environmentsPreferable IT background to understand larger impact of architecture technical complexities on the programExperienced in leading strategic and tactical discussions with Senior stakeholdersMBA and or Advanced degree MS MPH PharmD and or PhD is preferredPreferred Skills:Technology->Life Sciences->Regulatory Systems