Sr. Analyst

Full Time
Posted 1 month ago

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.

Job Features

Job CategoryFood

Apply Online