Mitul Modi Email & Phone Number

Ahmedabad, Gujarat, India

Indrad

• Facilitate third party audits i.e. FDA and other regulatory agency compliance inspections as well as corporate audits and co-ordinate the response.• Prepare quality reports and develop the standard operating procedure which affects operations and compliance status and co-ordinate of management review.• Conducting gap analysis to identify weak area and identify problematic issues at loan license site.• Maintaining product quality attribute at loan license site.• Assuring… Show more • Facilitate third party audits i.e. FDA and other regulatory agency compliance inspections as well as corporate audits and co-ordinate the response.• Prepare quality reports and develop the standard operating procedure which affects operations and compliance status and co-ordinate of management review.• Conducting gap analysis to identify weak area and identify problematic issues at loan license site.• Maintaining product quality attribute at loan license site.• Assuring consistent quality of product by implimenting and enforcing the training on GMP. • Monitoring product standards, reports of RM,PM and FG.• Periodically monitoring the retain sample and stability sample as per SOP.• Review the ongoing product stability study report.• Actively participate in market complaint, deviation and OOS investigation.• Prepare and reviewing the product quality report.• Actively participate in the process validation and hold time study. Show less

Surat, Gujarat, India

• Preparation and Review of URS/DQ/IQ/OQ and PQ protocol and reports.• Validation activities for different equipments (like; Snowbell Washing machine, Tunnel (Depyrogenating and sterilization), Filling and bunging machine, Sealing machine, Pharmlab Autoclave, DHS, Adam’s Manufacturing vessels with fully automated (system for filtration and transfer of bulk up to filling station).• Validation of lyophilizer: Preparation, Execution and report with their compilation of Tofflon Lyophilizer… Show more • Preparation and Review of URS/DQ/IQ/OQ and PQ protocol and reports.• Validation activities for different equipments (like; Snowbell Washing machine, Tunnel (Depyrogenating and sterilization), Filling and bunging machine, Sealing machine, Pharmlab Autoclave, DHS, Adam’s Manufacturing vessels with fully automated (system for filtration and transfer of bulk up to filling station).• Validation of lyophilizer: Preparation, Execution and report with their compilation of Tofflon Lyophilizer (with capacity of 400 kg).• Handling of HVAC system: Protocol preparation, Execution and report preparation. Also handle critical parameters of HVAC system by monitoring visually as well as by BMS system (Temperature, Humidity and differential Pressure).• Monitoring of Calibration activities of different critical instruments (I.e. Temperature sensors, Pressure Gauges, Temperature and Pressure switches, etc.)• Preparation of IOQ documents of the laboratory grade instruments.• Handling of QMS / Documentation system (I.e. Change control, Deviation, Incident, NCR etc.) From its logging procedure to closing with supporting systems.• Record, monitor, investigation with coordinating other departments and closing of Market complaint.• Preparation and Review of Standard Operating Procedures (SOP’s).• Co-ordinate with production, quality control, engineering and warehouse department for execution of process and media fill validation activity• Prepare, review and perform temperature mapping protocol and report for critical areas, instruments, equipments.• Handling and motivate of assistant regarding to plan work.• Participate in regulatory as well as costumer audits and finalize the audit compliance report.• Ensure that preventive and maintenance activity of equipments has been followed as per schedule plan.• Prepare batch manufacturing and batch packing record as per master formula card and bill of material.• Assist the technical and SOPs training. Show less

Sachin, Surat

Monitoring and handling of QMS and Validation activity

Ankleshwar

Monitoring the IPQA activity

Bachelor Of Pharmacy - Bpharm, Pharmacy

Diploma, Pharmacy