Summary
Overview
Work History
Education
Skills
Current location
Major Regulatory Audit
Recognition certification
External training attended
Current employer
Personal Information
Languages
Certification
Timeline
Generic
RITESH SINHA

RITESH SINHA

Varanasi

Summary

Experienced leader in the field of Quality, IT Quality and CSV with a strong track record spanning over Eighteen years in the Pharmaceutical sector. Proficient in both instructing and motivating others, with a talent for shaping and updating Standard Operating Procedures, Validation documents. Highly skilled in crafting, executing, sanctioning, and amending Equipment and Software Validation protocols, comprehensive knowledge of regulations. Exceptional interpersonal and customer service abilities, combined with a knack for organization. A collaborative team player with proven leadership capabilities. Self-driven, adaptable, and capable of juggling multiple responsibilities in high-pressure scenarios with minimal supervision. Proficient in various computer applications, as well as validation expertise in specialized software like Caliber-DMS ,Open text Documentum, ValGenesis, RELTIO –MDM,QUMAS, Laboratory instrument applications, Leucine tech software for e-log book, JDE. I hold the position of "Lead - Corporate CSV-IT (US Support)" at Amneal Pharmaceuticals in Ahmedabad, Gujarat

Overview

20
20
years of professional experience
1
1
Certification

Work History

Sr. Manager

Amneal Pharmaceuticals
Ahmedabad
07.2022 - Current
  • Leading Corporate CSV Team of 4 members
  • Presented knowledge sharing about CSV and SDLC to all US IT leads
  • Knowledge and follow CSA approach for all US applications
  • Part of 'All hands IT team' meeting led by SVP/CIO- IT (US)
  • 1:1 weekly session with Sr. Director –IT (US) on project status
  • Updating Global IT project tracker
  • Responsible for Project planning and tracking
  • Involvement with IT team during infra/server set up
  • Impart end users training on ValGenesis, DMS
  • Knowledge of Admin role of RELTIO-MDM, DMS, Leucine tech applications
  • Lead weekly meeting with US team for the status of current assigned projects
  • Leading Centralized excellence Global team for all CSV projects for India and US
  • Proactive approach for any road blockers during project
  • System admin and SME of ValGenesis for electronic validation
  • System admin and SME of Caliber DMS and Documentum system
  • Lead CSV for global application implementation like RELTIO-MDM, ValGenesis
  • Responsible for Review and approval of all deviations, defects observed during validation
  • Responsible for new candidate hiring for CSV.

Manager- Digitalization Team

Biocon Ltd-Banglore
Banglore
03.2021 - 07.2022
  • Plan, execute, and document validation processes for IT systems, including computer software, hardware, and infrastructure
  • This involves developing and executing validation protocols, conducting risk assessments, and managing change control processes
  • Participate in internal and external audits and regulatory inspections
  • Address findings and observations related to software validation
  • Promote data integrity and security by verifying data governance practices, data backup and recovery procedures, and access controls
  • Responsible for Hardware/ Infra set up and its qualifications as per specifications
  • Responsible for preparation and review of Computerized System Validation documents
  • Ensuring timely completion of deliverables as per approved Validation Plan
  • Coordinating with vendors on project activities status as per deliverables
  • Ensure review of SOW (Statement of Work) and other agreement document before project kick off
  • Preparation /Review of CSV validation documents as per GAMP5 guidance and applicable procedures
  • Preparation/Review of Functional Risk Assessment for the application
  • Impart Training to End Users about New application Functionality and Operation
  • Develop Admin and Operational Procedure for New Application
  • Coordination and discussion with IT team on infra part as per application requirements
  • Expertise on end to end to software validation as per SLC –GAMP5 guidance
  • Knowledge of Application integration with other Application
  • Providing Ideas for DMS application configurational enhancements to fulfill End user requirements
  • Seeking for better option to resolve the issues on timely basis
  • Ensuring compliance of Site Procedure and troubleshooting for day to day end user issues
  • End to End validation and implementation of 'Electronic Document Management System (Open Text Documentum D2, Version 20.2)'
  • Roll out of 'Electronic Document Management System' to all Business units
  • Discussion with Vendor on application configuration for Business Logic and custom requirements
  • Escalation of issues to Senior Management on timely basis
  • Planning and scheduling meeting with stakeholder on day to day basis
  • Understanding of business plan and Project planning
  • Participation in Application Cursory Testing and collating of all observations and Gaps
  • Closure and follow ups for open Gaps before Release of application to End Users.

Site Compliance and Validation Lead

Reckitt Benckiser- Uttarakhand
Uttarakhand
07.2019 - 02.2021
  • Responsible for cGMP compliance (21 CFR Part 210 and 211) and compliance to approved procedures for two sites
  • Conducting cGMP and training programmes
  • Planning and execution of supplier audits
  • Ensuring compliance of supplier management as per RB global requirement
  • Execution of Risk assessment for suppliers and its categorization as high, medium, low
  • Preparation of Supplier Audit report and follow up for CAPA action
  • Initiation of deviation in Trackwise and tracking of CAPA actions
  • Impart supplier training programme to strengthen their quality systems
  • Responsible for daily review meeting for Quality
  • To Lead in monthly and quarterly review meeting with Global Quality Head and discuss the quality related issues
  • Leading from Site for global overseas weekly and monthly Meeting
  • Responsible for to develop and initiation of Quality culture at site
  • Lead in all events related to quality
  • Handled Vision system project based on Deep Learning and AI for Online inspection
  • Review and tracking of all types of green and brown field projects
  • Review and approval of SOPs
  • Responsible for to review all Quality KPI and leading, lagging indicators
  • Responsible for Supplier Qualification, preparation of audit plan, SOP and Agenda.

Astt. Manager-QA

Dr. Reddys Lab Ltd-CTO- VI(API)-Vishakapatnam
Vishakapatnam
07.2015 - 06.2019
  • Monitoring of cGMP compliance (21 CFR Part 210 and 211) and compliance to approved procedures
  • Conducting cGMP and On-job training programs
  • Support in major internal and all external regulatory audits
  • Responsible for all engineering assurance activities
  • More than 10 major projects successfully completed
  • Review and approval of all types Water System Qualification, HVAC, Computer system validation (GAMP5) documents
  • Experienced professional in Pharmaceutical and healthcare compliance domain with wide experience in GXP, 21 CFR part 11, GAMP 5 and other compliance requirements and adherence
  • Complete understanding on SDLC and Software Assurance
  • Experience in preparation of test scripts as per software design
  • Review and tracking of all types of green and brown field projects
  • Leading Role in Engineering Assurance team
  • Major Automation and CSV project handled independently (LIMS, BMS, DCS, DAS)
  • Review and approval of Automation related Projects- DCS, BMS, RPHPLC, Weighing balance
  • Implementation of E-log book and MES in manufacturing blocks
  • Thorough knowledge of PLC process, programming, communication protocols
  • Review and approval of MES, DCS, test scripts
  • Major involvement during validation and testing phase of PLC and Sensors
  • Balance, ROA and BPR printing through SAP, WMS, LIMS
  • Review and approval of Water annual Report
  • Review and approval of SOPs.

Sr. Executive -QA

Ipca Lab Ltd- (Formulation)-Ratlam
Ratlam
07.2014 - 06.2015
  • Manage a team of 5 members as a Lab QA in-charge
  • Major responsibility to review compliance of all laboratories in site
  • OOS investigation, CAPA implementation and tracking, participating in root cause identification through brainstorming and other effective tools
  • Daily team meeting to track the status of CAPA, change control, incidents, OOS
  • Communication with vendors and regulatory for OOT and other raw material issues.

Executive – Stability QA/QC

Indchemie Health Spl.Ltd (Formulation- Alkem Groups)-Baddi
Baddi
04.2010 - 06.2014
  • Supervised a team of twelve analysts
  • Review and approval of SOP's, STP's and Specifications related to QC and stability
  • Review of analytical documents
  • Ensuring all the analysts to follow SOP's and perform testing as per approved test procedures
  • Participating in customer audits and Co-ordination with operations group for timely releases of Raw materials and Finished product testing
  • Maintenance of stability section activities, protocol review and approval, trend and COA preparation as per customer requirement
  • Expertise in handling of all critical and basic instruments of quality control.

Officer-QC

Dabur India Ltd (Formulation-Baddi)
Baddi
01.2008 - 04.2010
  • Responsible for analysis and release of raw material, finished products, packaging materials, art work approval, vendor qualification, Calibration of instruments
  • Maintenance of lab according to GLP
  • Preparation and review of method validation protocols and reports
  • Trouble shooting of routine analytical issues
  • Preparation of Standard operating procedures and review of analytical documents.

Sr.Officer QC

Galpha Labs Ltd (Formulation-Alkem Group)-Baddi
Baddi
12.2005 - 01.2008
  • Analyzing samples according to Regulatory market requirements
  • Calibration of instruments Maintenance of lab according to GLP
  • Preparation of STP's and work sheets for regular analysis
  • Maintaining calibration records for all analytical instruments
  • Preparation and qualification of in-house working standards
  • Review of analytical documents
  • Analyze and release of Raw materials, Packaging materials, In-process, Finished product, and Stability samples Hands on experience in the analysis of Liquid Orals, and suspensions.

Chemist –QC

Venus Remedies Ltd (Parentals-Panchkula)
Panchkula
07.2004 - 12.2005
  • Analysis of raw materials, packaging materials
  • Analysis of injectables products
  • Maintenance of lab as per GLP.

Education

M.Sc.(Chemistry) -

Kalinga University, Kalinga University
01.2005

B.Sc.(Botany,Chemistry) -

Udai Pratap College, U. P. Board
01.2002

Intermediate -

M.B.I.C, U. P. Board
01.1998

High School -

M.B.I.C, U. P. Board
01.1996

Skills

  • Quality
  • IT Quality
  • CSV
  • CompTIA Network
  • CCNA
  • Manual Software tester
  • SDLC
  • JIRA
  • Project Management
  • Resource Planning
  • Equipment and Software Validation protocols
  • Team player
  • Leadership capabilities
  • Computer applications
  • Caliber-DMS
  • Open text Documentum
  • ValGenesis
  • RELTIO –MDM
  • QUMAS
  • Laboratory instrument applications
  • Leucine tech software
  • JDE

Current location

Ahmedabad, Gujarat

Major Regulatory Audit

  • USFDA (Two times)
  • TGA
  • MHRA
  • Health Canada
  • ANVISA
  • PMDA
  • China FDA
  • COFEPRIS
  • More than 50 external customer audit faced

Recognition certification

  • Special recognition for extensive support in new facility creation in CTO-VI for Sugammadex product
  • Received training and certification on DMS System Admin training from Open Text

External training attended

  • Special 2 days training attended organized by Global Compliance Panel –Mumbai
  • Topic- Good Laboratory Practices, External Lab testing compliance

Current employer

Amneal Pharmaceuticals

Personal Information

  • Father's Name: ARUN KUMAR SINHA
  • Title: Lead - Corporate CSV-IT (US Support)
  • Date of Birth: 03/08/1980
  • Marital Status: Married
  • Religion: Hindu (Kayastha)

Languages

Hindi, English

Certification

  • Certification in CompTia N+ and CCNA.
  • Certification in Manual software testing from STAD Solution.

· “Certified quality auditor for Internal Inspection”

· “Certified Internal auditor from TUV/SUD -IA QMS9001:2015”

· “Approved chemist from Indian FDA (Dehradoon)”

Timeline

Sr. Manager

Amneal Pharmaceuticals
07.2022 - Current

Manager- Digitalization Team

Biocon Ltd-Banglore
03.2021 - 07.2022

Site Compliance and Validation Lead

Reckitt Benckiser- Uttarakhand
07.2019 - 02.2021

Astt. Manager-QA

Dr. Reddys Lab Ltd-CTO- VI(API)-Vishakapatnam
07.2015 - 06.2019

Sr. Executive -QA

Ipca Lab Ltd- (Formulation)-Ratlam
07.2014 - 06.2015

Executive – Stability QA/QC

Indchemie Health Spl.Ltd (Formulation- Alkem Groups)-Baddi
04.2010 - 06.2014

Officer-QC

Dabur India Ltd (Formulation-Baddi)
01.2008 - 04.2010

Sr.Officer QC

Galpha Labs Ltd (Formulation-Alkem Group)-Baddi
12.2005 - 01.2008

Chemist –QC

Venus Remedies Ltd (Parentals-Panchkula)
07.2004 - 12.2005

M.Sc.(Chemistry) -

Kalinga University, Kalinga University

B.Sc.(Botany,Chemistry) -

Udai Pratap College, U. P. Board

Intermediate -

M.B.I.C, U. P. Board

High School -

M.B.I.C, U. P. Board

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