Deputy Manager Quality Assurance (CSV)

Solan - India

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

To monitor and ensure that all GxP-impacting computerized systems remain in a state of regulatory compliance.
To write revise and continuously update Standard Operating Procedures (SOPs) to align with current regulatory requirements.
To ensure the timely implementation of validation policies and SOPs throughout the organization.
To prepare/ review validation and qualification documents related to computerized systems.
To manage the completion of validation activities and periodic reviews of systems to maintain their validated state.
To assess system functionalities against regulatory requirements during system selection assessments or Factory Acceptance Testing (FAT).
To participate in in-house customer and regulatory agency audits at site to explain CSV activities.
To coordinate with vendors for end-to-end validation and outsourced activities including evaluating vendor capabilities.
To participate in the selection and discussion of computerized system vendors during the project phase.
To act as a coordinator between corporate functions and site functions to ensure smooth validation execution.
To ensure and follow the eQMS (TrackWise Digital Quality Management System) elements (Change Control Investigations Market Complaints Self-Inspections Incidents Quality Risk Management etc.) in the state of compliance.
To conduct training related to GxP impacting computerized system validation approach computerized system lifecycle maintenance current regulatory requirements and guidelines

Required Experience:

Manager

To monitor and ensure that all GxP-impacting computerized systems remain in a state of regulatory compliance.To write revise and continuously update Standard Operating Procedures (SOPs) to align with current regulatory requirements.To ensure the timely implementation of validation policies and SOPs ...