Ashesh Tripathi Email & Phone Number

Daman

Daman, Daman And Diu, India

Jaipur, Rajasthan, India

Overall responsible for Quality Assurance and compliance functions of OTC Block including Manufacturing (IPQA), Quality Control, Microbiology, Engineering, and Warehouse.Review, monitoring, and oversight of Quality and compliance functions to prepare the site for all time readiness for USFDA inspection. Responsible for reviewing all investigations of Deviations, OOS, and OOT.

Dewas Area, India

IPQA of Injectables (Carbapenems Vial Filling Facility) and OSD Manufacturing Facility.Qualification & Validation of Sterile Manufacturing facility (Vial Filling Facility) viz. Autoclave, Vial Washing Machine, Depyrogenating Tunnel, Vial Filling Machine, Vial Sealing Machine, LAFs and Pass Boxes etc.).Media Fill Validation, Water System Validation (Purified Water and WFI) and HVAC System. Qualification & Validation of Oral Solid Dosages Manufacturing facility viz. Compression Machine, Coating Machine, FBD and Blender, Process Validation and Hold time study of Tablet Manufacturing.Designing of Cleaning Validation Study and Execution, Dirty and Cleaned Equipment Hold time Study.Responsible for reviewing all investigations of Deviations, OOS and OOT.Audit & Compliance, Handling of QMS viz. Handling of CAPA, Product Quality Complaints, Technical Agreements with different customer/countries, MA Holders, Handling of Recall (Pharmaceutical Finished Dosages form), Coordinator of Site Quality system Management Review Meeting, Quality Review Board (QRB) Meeting, Change Controls, Investigation and Root cause Analysis, Transport Validation etc.

Mandideep

IPQA of OSD and Parenteral sections (Cephalosporin Vial Filling Facility).Process Validation (OSD Manufacturing) & monitoring during execution.Review of Validation & Qualification of Vial filing facility and OSD Manufacturing (Process, Cleaning, URS, DQ, IQ, OQ, PQ of Equipment, water validation, AHU Qualification etc. utility Validation) and monitoring during execution.Review of Batch production Records (BPRs), Analytical Records and release of batches before distribution.Handling of QMS viz. Preparation of Annual Product Review and evaluation of trend for early indication of product quality drift, Handling of Change Controls, Deviation, OOS and OOT etc. Handling of Market Complaints, Preparation of Site master file (SMF) & Validation Master Plan (VMP), SOP Preparation & review etc.Audit & Compliance for Internal, External & Regulatory Audit.Coordination with Regulatory Affairs during submission of the Annual update, response, ANDA Submission etc.

Mandideep

Process Validation of OSD (Tablets) i.e. Preparation of Process Validation protocols, execution of the study and report compilation.In process Checks and shop floor inspection activities (IPQA), in Oral (Tablets, Capsules, Liquid, Dosage Form) and in Parenteral section.Preparation of Batch Manufacturing Records (BMRs) and Standard Operating Procedures.Review of Batch Manufacturing Records, Batch Packing Records, Analytical Records and release of finished goods.

Ratlam, Madhya Pradesh, India

Process Validation, Cleaning Validation and Analytical Method Validation.

Bachelor In Pharmacy, Pharmacy, First Division

Bachelor in Pharmacy.

Higher Secondary School Certificate, Physics, Chemistry, Biology, First Division With Distinction

Passed Higher Secondary School Certificate in 1994 from Madhya Pradesh Secondary Education Board, Bhopal.

Hsc, Science

Activities and Societies: Passed High School in 1992 with distinction Passed High School in 1992 with Distinction