GOPAL PATIL

Proficient Quality Analyst with QMS and CSV experience. Consistently works with minimum supervision. Independent and self-directed. I have Strong attention to detail skills, award winning educational background, and ability to work as a team player looking forward for new challenges and opportunities.

Sampling, Analysis, Calibration and Routine Activities:

• Sampling and analysis of Raw Materials, In-Process samples, Packaging Materials, Water and Consumables.
• Handling of equipment's like FTIR, UV-Vis Spectrophotometer, HPLC, Refractometer, Melting Point Apparatus, Autotitrator, KF titrator, Polarimeter, Viscometer, Densitymeter, Atomic Absorption Spectrophotometry (AAS) and TOC Analyzer.
• Calibration of various equipment's like Autotitrator, KF Titrator, Polarimeter, Refractometer, pH/Conductivity meter, FTIR and Analytical Balances.
• Daily temperature monitoring of cold rooms, deep freezers and quality control laboratories laboratories.
• Handling and Management of Chemicals, Reference Standards and Reserve Samples.

Qualification and Computer System Validation (CSV):

• Preparation of CSV documents like User Requirement Specification (URS), High Level Risk Assessment (HLRA), Software Vendor Assessment (SVA), Functional/ Design Specification (FDS)/Configuration Specification (CS), Validation Plan (VP), Functional Risk Assessment (FRA), Traceability Matrix (TM) and Validation Summary Report (VSR).
• Preparation execution of computer system validation and qualification protocols like installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and migration qualification (MQ).

Quality Management System (QMS):

• Handling of QMS elements like change controls, incidents and OOS in TrackWise Digital (TWD).
• Involved in an investigations of incidents/OOS as a part of investigation team.
• Proposal and management of Corrective Actions and Preventive Actions (CAPA).
• Initiation of change controls for equipment qualifications, CSV activities, specification and SOP revisions.
• Preparation of risk assessment report like Failure Mode Effective Analysis (FMEA), Specifications,SOP's, Analytical Method Validation protocols, Reagent and Volumetric solutions stability protocols, Justification reports and Summary reports related to quality control analytical laboratory.
• Pharmacopoeia Evaluations: Monthly evaluation of pharmacopoeia updates from Pharmacopoeia European (EP), United States of Pharmacopoeia (USP), Indian Pharmacopoeia (IP) and other regulatory guidelines like ICH.
• Departmental Training Coordinator (DTC): Management and tracking of department trainings in in eLMS (Electronic Learning Management System).

Biocon-KGI Certificate Programme in Bioscience:

• Course focused on functional visits to manufacturing, quality, regulatory and R&D.
• An overview of drug development and role of regulatory.
• An introduction to DMF and DMF fillings in regulated markets.
• Case studies of DMF filing.
• Brief introduction to CTD, eCTD and its modules.
• An overview of Intellectual Property Rights (IPR).
• An overview of biosimilar regulations and registration pathways (USA, Europe and
  region specific).
• Introduction to New drug approvals (NDA) in USA, Europe, Japan and emerging
  markets.
• An overview of Indian regulatory scenario and CDSCO.
• Introduction to various regulatory authorities and their regulations.

• Quality Champion Award-2020 (Aurobindo Biologics, Unit-17)
• Best DTC (Department Training Coordinator) Award-2024

• Gold Medalist (B.Pharmacy)

• GPAT Qualified -2016 (AIR-503)

• R.C. Patel Excellence Award from 2011 to 2015