Performing Stability analysis, Method transfer and Method Validation.
Preparation and review of Method Transfer Protocols, Standard Testing Procedure, Test Data Sheet for Stability Analysis, Method transfer and Method Validation, Stability Summary Reports and any document related to stability analysis, method transfer and method validation in compliance with current guidelines. Review and maintenance of all logbooks of the department
Preparation of departmental SOP’s in compliance with current guidelines. Review of departmental SOP’s, training of analysts and other technical staff and review validation of data transfer, data management using computer systems.
Preparation and review of validation protocols in compliance with current guidelines.
Calibration and validation of all instruments / equipments.
Procurement of columns, chemicals/ reagents/ solvents and standards for various stability analysis, method transfer and method validations.