We are seeking a highly skilled Business Consulting : Computer System Validation professional to lead project compliance workstreams. The ideal candidate will be responsible for the end-to-end quality and compliance aspects of projects, ensuring successful delivery and client satisfaction.
Key Responsibilities
- Lead project compliance work streams, overseeing the end-to-end quality and compliance aspects of a project.
- Be responsible for validation deliverables, client buy-in, and reporting to ensure successful project delivery.
- Engage with key stakeholders for day-to-day interactions with client teams.
- Participate in practice development activities.
- Establish, implement, and monitor quality management requirements to assure that IT projects meet quality and regulatory requirements.
Skills Required
Strong business consulting and excellent soft skills.Proven success in and thorough understanding of Computerized System Validation (CSV) .Knowledge of key Pharmaceutical compliance regulations such as 21 CFR Part 11, GxP, GAMP 5, and SOX IT .Subject matter expertise in areas like Quality Management, document management, and Change Management .Knowledge of various Validation tools and templates used in the pharmaceutical industry.Working knowledge of Risk Management, periodic or control maturity assessment, and Audits .Must have global client exposure and experience working in a Global delivery model.Bachelor's / Master's degree, preferably in pharmaceutical sciences or a related field.Skills Required
computerized system validation , Quality Management, Document Management, Change Management, Risk Management, Audits