Job description

• CSV Lead for assigned projects; responsibilities include but not limited to vendor evaluation, creation of Validation Plan based on the criticality of the proposed system, in consensus with the vendor, based on their Quality Systems.
• Perform system risk assessments and review action plans to ensure compliance during and after the system validation.
• Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and version release protocols.
• Develop and review computer system validation deliverables for accuracy, consistency, clarity, and completeness.
• Reviewing, approving Test script/ Qualification – Perform assigned activities, deliverables, CFT meeting co-ordination
• Help, guide and direct the project manager during the system implementation and validation process, ensure compliance with Dr. Reddy s policies and procedures.
• Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel.
• Ensure the compliance of computerized systems to regulatory requirements, including but not limited to 21 CFR Part 11 and other applicable regulations.
• Review of change controls with respect to business process, any changes in IT system. Review of validation deliverables for IT Change Requests; Establishing and implementing corrective and preventive actions and process improvements initiatives for CSV projects.
• Facing regulatory, customer, IT Quality System related inspections for all computerized systems across the company.
• Review of computerized systems post go-live to ensure compliance with the applicable procedures.
• Undertake knowledge management initiatives (GxP awareness, Compliance sustenance) like Trainer-Training related to CSV/quality /compliance to cross functional teams.