Consultant - Business (Life Sciences/Healthcare)

Job Description:

• What are we looking for
• Analysts Consultants Senior Consultants
• We are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellence
• Our analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skills
• We 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 experience
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation 21 CFR part 11 GxP GAMP 5 SOX IT Data Privacy Data Integrity and Information Security
• Subject matter expertise in areas such as Quality Management document management and Change Management
• Establish implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
• Knowledge of Risk management perform root cause analysis on trends and address deviations via preventive detective and corrective measures
• Experienced in Validation of SAP S4 HANA projects
• Knowledge and hands on experience conducting periodic or control maturity assessment and Audits
• Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry
• Successful track record using Lean Agile approaches to validate assets
• Proven ability in handling multiple large projects respond quickly to changing situations in complex environments
• Preferable IT background to understand larger impact of architecture technical complexities on the program
• Experienced in leading strategic and tactical discussions with Senior stakeholders
• MBA and or Advanced degree MS MPH PharmD and or PhD is preferred

Key Responsibilities:

• What are we looking for
• Analysts Consultants Senior Consultants
• We are looking for smart self driven high energy people with top notch communication skills intellectual curiosity and passion for excellence
• Our analysts have a blend of in depth domain expertise strong analytical and conceptual thinking skills and excellent soft skills
• We 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 experience
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation 21 CFR part 11 GxP GAMP 5 SOX IT Data Privacy Data Integrity and Information Security
• Subject matter expertise in areas such as Quality Management document management and Change Management
• Establish implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements
• Knowledge of Risk management perform root cause analysis on trends and address deviations via preventive detective and corrective measures
• Experienced in Validation of SAP S4 HANA projects
• Knowledge and hands on experience conducting periodic or control maturity assessment and Audits
• Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry
• Successful track record using Lean Agile approaches to validate assets
• Proven ability in handling multiple large projects respond quickly to changing situations in complex environments
• Preferable IT background to understand larger impact of architecture technical complexities on the program
• Experienced in leading strategic and tactical discussions with Senior stakeholders
• MBA and or Advanced degree MS MPH PharmD and or PhD is preferred

Preferred Skills:

Technology->Life Sciences->Regulatory Systems