Consultant - Business Consulting (Life Sciences/Healthcare)
- Noida, Uttar Pradesh
- Permanent
- Full-time
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