Description
Provide pharma regulatory compliance consulting to development projects.1.Deliver ISRM services to the client they are part of to help ensure that information and IT systems are adequately protected against unauthorized disclosure (confidentiality), unauthorized alteration (integrity), unavailability (availability) and non-compliance
2. To ensure identified project methodology is followed and deliverables are produced in line with validation approach
3. Driving achievements of the Validation/Quality goals by ensuring that the process and standards defined for the project are followed
Mandatory Skills
1.GxP, 21 CFR Part 11, SDLC, GAMP knowledge and SOX knowledge
2. Preparation for compliance audit, attending meetings and assisting in addressing any issues. Also Supporting PM in risk management activities
3.Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Computerized System Validation concept