Shashank Trivedi

• Responsibilities.
• Literature search for product related information.
• Analytical method development and validation of drug Substance and drug products (Assay, RS and Dissolution).
• Preparation of MDR and DDR.
• Preparation of working standard and Impurity Standard.
• Analysis of development/stability samples using HPLC, Dissolution apparatus, UV-Visible spectrophotometer and other general instruments.
• Calibration/Performance check of assigned / designated Instruments.
• Documentation of activities performed.
• Review of laboratory documents.
• Maintaining laboratory for SOP’s and system compliance.
• Analytical data and STP review.
• Authored technical documents outlining research processes, procedures and findings

· Calibration and maintenance of Analytical instruments, UV spectroscopy, Dissolution, Karl- Fisher, Disintegration Apparatus, Friability Apparatus.

· Analysis of finished products, In process samples, validation and cleaning samples.

· Preparation of analytical report after analysis for all the finished products, In process and validation samples.

· Investigation of incidents and OOS results

Review of analytical data and reports.

• Monitored testing procedures and verified performance of tests according to established item specifications and protocol

• Reporting to In Charge QC.
• (In process and finished products).
• Responsible of all QC-Operational and calibration for lab instrument.
• Instrumental analysis of In process and Finished Product as per STP.
• Preparation, Implementation, testing procedures, certificate of analysis.
• Maintaining usage log book and daily worksheet.