Jiten kumar Maheshbhai Joshi

• Executed daily SPC/STP planning to enhance operational efficiency.
• Prepared, revised, and reviewed documentation for SPC/STP processes.
• Developed SPC/STP documents for Packaging Material and Raw Material projects.
• Conducted preparation and review of SPC/STP related to In-Process, Finished Product, and Shelf-Life studies.
• Managed Change Control documentation for SPC/STP updates and process modifications.
• Compiled and submitted PDC documentation to ensure compliance.
• Prepared closure reports after comprehensive review and approval.
• Created Change Control documentation to support process improvements.

• Prepared SPC, STP, and protocols for raw materials and finished products.
• Executed daily planning for raw materials to ensure efficient workflow.
• Reviewed and released raw material testing protocols in Pharmacloud and COA.
• Managed release processes for in-process and finished products in Pharmacloud and COA.
• Evaluated water testing protocols for compliance and accuracy.

TECHNICAL SKILLS AND KNOWLEDGE:

Having skills and experience to handle the instruments like

• UV visible Spectrophotometer (Shimadzu-UV-1800),
• FTIR (shimadzu)
• Auto Titrator (Lab India)
• HPLC ( Thermoscientific)

• Executed detailed reviews of protocols, COA, and various product analysis documents.
• Analyzed bulk and finished products to ensure compliance with specifications.
• Scheduled calibration of analysis instruments to maintain operational accuracy.
• Standardized reagents and volumetric solutions for reliable testing results.

TECHNICAL SKILLS AND KNOWLEDGE:

Having skills and experience to handle the instruments like

• UV visible Spectrophotometer (Shimadzu-UV-1800),
• Dissolution Test Apparatus(Electrolab and Lab India),
• Disintegration Time Apparatus(Electrolab)
• LPC ( Liquid particulate counter )
• FTIR (Shimadzu)
• HPLC ( Thermoscientific)

• Ensured daily calibration of pH and conductivity meters for reliable data collection.
• Analyzed bulk and purified water to meet established quality benchmarks.
• Documented all instrument calibration activities to maintain clear records.
• Evaluated packing materials through rigorous testing to ensure compliance with safety standards.

• Conducted daily calibration of pH and conductivity meters to ensure accuracy.
• Performed sampling and testing of raw materials for quality assurance.
• Released raw materials upon successful completion of testing protocols.
• Affixed under test and approved status labels on compliant materials.
• Executed testing procedures for bulk, finished products, and all packing materials.
• Tested purified water, raw water, and finished products for regulatory compliance.
• Maintained comprehensive records for all instrument calibrations performed.
• Executed thorough testing of raw materials and finished products to uphold standards.

Having skills and experience to handle the instruments like

• UV visible Spectrophotometer (Shimadzu-UV-1800),
• FTIR (Cary 630 FTIR)
• TOC - total organic carbon ( Sieveres M9 )