Business Consulting : Computer System Validation

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.