•• Sound knowledge on analytical method developments, method validations, impurity profiling, technology transfer for various formulations,
• Sound knowledge on quality & regulatory and knowledge of cGMP, USFDA, EDQM, ICH, JP guidelines.
• Sound knowledge of SOP, Method of Analysis, Protocols, Validation Protocol & Report writing.
• Preparation of Analytical method development and validation report and protocol
• Product related troubleshooting, effective troubleshooting for the method validation issues, Analytical Method related troubleshooting, Design of experiment.
• Timely calibration and maintenance of equipment and instruments
• Strong knowledge of stability guidelines, stability ...