Summary
Overview
Work History
Skills
Accomplishments
Certification
Timeline
Generic
Achut Bhagwat Davhare

Achut Bhagwat Davhare

Senior Consultant at Infosys
Aurangabad,Maharastra

Summary

Looking forward to a challenging career in an organization where I can sharpen my professional skills and experience and work at a position where my ability for innovative decision making could be tapped. Professional Overview A diversified of 10+ years’ experience in Pharmaceutical and Life Science as Computer System Validation (CSV) GxP/Non GxP System, and Software Development Life Cycle - SDLC. Hands on experience in QMS and good understanding of GxP (GMP, GLP& GDP) standards and 21 CFR Part 11and EU Annex 11. Extending high-end technical support and ensuring high customer satisfaction levels through prompt redresses of their problems. Excellent communication and interpersonal skills with proven abilities in resolving complex Situation, and application related issues.

Overview

22
22
years of professional experience
1
1
Certification
1
1
Language

Work History

Senior Consultant

Infosys Ltd.
Pune, Maharashtra
12.2021 - Current
  • Self-motivated, with a strong sense of personal responsibility.
  • Worked effectively in fast-paced environments.
  • Skilled at working independently and collaboratively in a team environment.
  • Proven ability to learn quickly and adapt to new situations.
  • Excellent communication skills, both verbal and written.
  • Worked well in a team setting, providing support and guidance.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.
  • Passionate about learning and committed to continual improvement.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Organized and detail-oriented with a strong work ethic.
  • Paid attention to detail while completing assignments.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Strengthened communication skills through regular interactions with others.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Learned and adapted quickly to new technology and software applications.
  • Proved successful working within tight deadlines and a fast-paced environment.
  • Developed and maintained courteous and effective working relationships.
  • Demonstrated strong organizational and time management skills while managing multiple projects.

Associate, Executive

Harman Finochem Limited
Aurangabad
05.2017 - 12.2021
  • Experience in Computer System Validation / IT Regulatory Compliance and strong core pharma experience
  • Manage validated state of IT applications and define Quality Management Process
  • Prepare / Execute / Review Software/IT systems validation documents in close cooperation with project team members and IT vendors throughout the entire IT system/ software development life cycle
  • SDLC documentation (Validation plan, URS, FS, DS, IQ, OQ, process gap analysis, traceability matrix, Validation Report), 21 CFR part 11 and GAMP5
  • Audits faced- USFDA, EUROPE and Vendor Audit
  • Handling change control deviation (Trackwise As well as Caliber QAMS) preparing CAPA and investigation, Risk Assessment and planning for Risk mitigation
  • Chromeleon 6.80 / 7.2 Software Installation and Qualification as per GAMP5 category
  • As an IT Administrator of Quality Control Department support to different instrument applications, Instruments related to communication and network and Servers, client and Standalone instrument computer systems
  • Taking care of Chromeleon and Empower Servers, Managing & Monitoring, yearly Database creation database Mounting / un-mounting, data archival and Retrieval
  • Responsible for DCS System user management, Data Backup and retrieval
  • Software validation, In-House Performance Qualification, Operational SOP
  • SAP S4HANA implementation with CSV compliance
  • Playing the role Validation coordinator between business users and HANA implementation team
  • Performed prospective validation assessment and gap analysis for application/tool
  • To ensure compliance with 21 CFR Part 11 requirements & GxP standards
  • Understand application/tool and its workflow and define the validation strategy and define validation deliverables
  • Authoring and reviewing Validation deliverables: Validation Risk Assessment, Validation Plans, User Requirement Specifications (URS) review and Functional Requirement Specifications (FRS) review and Requirement Trace Matrix (RTM) using SOLMAN ALM tool
  • Involved in writing, review, and execution of Validation Protocols
  • Provide quality oversight to complex qualification activities and projects including timely review and approval of project and process validation plans, protocols, summary reports and deviations to ensure project timelines are not impacted
  • Reviews/updates/assists in developing CSV standard operating procedures (SOPs)
  • Maintaining training records and compliance for entire program team
  • Work on Infrastructure setup of ODC, setup of ODC manual and its internal audit part.

Officer

IPCA Laboratories Limited
Aurangabad
06.2015 - 05.2017
  • Computer System Validation
  • Experienced in GxP& Risk Assessment, 21 CFR part 11/GAMP-5/EU Annex 11 compliance assessment & its application in software validation
  • Key Quality Personnel role in End to End Validation planning and Project execution for Software / IT systems in GxP (GCP, GMP, and GLP) Area
  • Prepare application for audits / assessments and provide support during audits / assessments
  • Taking care of company business data and Critical Data Backup and Restoration
  • User Creation / modification / Deactivation in Chromeleon software and NON CDS instrument software
  • (UV, FTIR, Polarimeter, Potentiometer, Stability, Malvern, TOC, UV Cabinet, etc.)
  • Preparation of SOP Review and Finalization
  • Preparation of Protocols and Reports
  • Handling of Deviations and Change Control in trackwise
  • Handling SUMMIT application for Incidence management and call logging for GxP system.

IT

Ajanta Pharma Limited
Aurangabad
01.2013 - 06.2015

Desktop support Engineer

Ashok InfoTech
04.2010 - 12.2012

Administrator

01.2010 - 01.2013
  • Qualification
  • Master of Computer Application Year-, INSTITUE OF MANAGEMETNT STUDIES &INFORMATION TECHNOLGY AURANGABAD) Under Dr.B.A.M
  • University Aurangabad, Team size: 2000+ (Multi National Group)
  • Contact person: Mr.SandeepAmlekar (DGM-IT

Babasaheb Ambedkar University, Maharashtra Board
Aurangabad
01.2007 - 01.2009
  • H.S.C
  • From

S.S.C
01.2003 - 01.2004
  • (74.80%)
  • Job Profile
  • Total Experience: 10 + Year
  • Relevant Experience: 7 + Year
  • Notice Period: 3 Month Lieu of 2 month Basic.

Skills

  • Computer System Validation
  • End to end Computer system validation, Self inspection, SDLC documentation (Validation plan, URS, FS, DS, IQ, OQ, process gap analysis, traceability matrix, Validation Report), 21 CFR part 11 and GAMP5
  • Extensively authored and reviewed, system life cycle documents such as IQ (Installation Qualification), OQ (Operational Qualification), Validation summary report, Impact Analysis, etc
  • Good working knowledge of Validation, Manual, Functional testing in diverse applications under Life Sciences domain
  • IT Skills
  • Operating Systems: Windows 98, Windows NT, 2000, XP, Windows 7, Windows Vista, windows 8, Windows 81, Windows 10
  • Server Operating Systems: Windows Server 2000, Server 2003, Server 2008, Server 2008 R2, Server 2012R2, Server 2016
  • Tools and Utilities
  • Languages:
  • C, C, Visual Basic 60, VBNet, C#, ADONet, java
  • Back End: MS SQL Server 2008, Mysql, Oracle 10g basic
  • Current Location:
  • Aurangabad
  • Personal Dossier
  • Name : - Achut Bhagwat Davhare
  • Gender : - Male
  • Marital status : - Married
  • Nationality : - Indian

Accomplishments

  • Perform Quality Risk Management and Computer System Validation
  • Preparation Validation summary report, SOP Management Log, Risk Assessment
  • Professional experience in Validation Practices with a good understanding of GxP (GMP, GLP and GCP) standards and 21 CFR Part 11
  • Review of Test cases and Preparing RTM
  • Performing IQ, OQ and PQ for software
  • Perform Quality Risk Management and Computer System Validation
  • Performing IQ, OQ and PQ software
  • Qualification for laboratory instrument
  • Preparations of SOP and in-house methods to meet US-FDA & GMP Requirement
  • Since Sep 2009 to March 2010 Associated with Expert Solution India Pvt Ltd as Desktop support Engineer
  • Job Responsibilities:
  • Varroc Appliances India Pvt
  • Ltd
  • Installation &Configuration of Windows 2003 Server with ADS, DHCP & DNS, Group Policy, User Rights, Disk Quota
  • Yeshshree press comp, waluj
  • Residence engineer
  • Installation & Configuration of All Network Printers
  • Installation & configuration of kayspersky Antivirus 10.1 for 50 users.

Certification

Global Computer Training Academy, AppaBalwantchauk Pune. Cisco Certified Network Administrator: CMS Computer Aurangabad. Microsoft Dot.Net 4.0 Pears Technology, Hyderabad.

Timeline

Senior Consultant

Infosys Ltd.
12.2021 - Current

Associate, Executive

Harman Finochem Limited
05.2017 - 12.2021

Officer

IPCA Laboratories Limited
06.2015 - 05.2017

IT

Ajanta Pharma Limited
01.2013 - 06.2015

Desktop support Engineer

Ashok InfoTech
04.2010 - 12.2012

Administrator

01.2010 - 01.2013

Babasaheb Ambedkar University, Maharashtra Board
01.2007 - 01.2009

S.S.C
01.2003 - 01.2004

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Achut Bhagwat DavhareSenior Consultant at Infosys