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Performing Stability analysis, Method transfer and Method Validation.
Preparation and review of Method Transfer Protocols, Validation protocols and all related protocols, procedures and reports.
To carry out analytical method development, method validation and testing of impurities in finished products on LCMS/MS and GCMS/MS
Performing calibration for GCMSMS, LCMSMS system, micropipettes and performing the In-House Preventive maintenance of GCMSMS and LCMSMS
Preparation, review of departmental SOP’s and training of analysts.
Calibration and validation of instruments / equipments.
Review and maintenance of all logbooks in the department.
Procurement of columns, chemicals/ reagents/ solvents and standards for Stability analysis, Method Transfer and Method Validation.
Detailed description of MAIN tasks and responsibilities:
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.
MSc / B Pharm, M Pharm with 08-10 years of Experience.
Manager QC
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