Nitin choudhary
Manager QA
Indore, Colony Indore
Summary
An energetic enthusiastic personal having 11+ years of experience with exposure on Audit & Compliance, Pharmaceutical Quality System Management, Vendor Qualification & Computerized System Validation in life sciences industries want to seek a position where I can utilize my experience, knowledge, and skills to benefit the organization.
Competence Forte
Total Experience 10+ years Dynamic Pharmacy professional with over 10+ years of distinguished career in reputed Organization in Quality control, Quality Assurance & Information technology with production strategies with competency.
- Efficient in Handling – LIMS (Labware), Open lab, ComplianceX, Opus, Lab solution,Carywin, Mass Hunter, Servicenow, Compliancewire, Jira, X ray, Veevavault , KNEAT and TOSCA.
- Inherent focus on high - quality, systems, processes and structures with stress on efficiency and effectiveness leading to better quality products. Excellent communication, interpersonal & man management skills, multilingual with proficiency in English, Hindi.
Overview
12
12
years of professional experience
7
7
years of post-secondary education
2
2
Languages
Work History
Sr.CSV Consultant
PQE Group
INDORE, MADHYA PRADESH
06.2022 - Current
- Responsible for implementation of KNEAT Software for BACE -II Projects (MES).
- Provide support for change management procedures and process with stakeholders.
- Accountable for the preparation, execution and development of validation life cycle documents including
Compliance Analysis, Validation Plan, User Requirements / Functional Requirements Specification,
Configuration & Design Specification, IQ/OQ/PQ protocols creation and execution, Validation Report,
Traceability Matrix as well as Index Matrix - Support activities related to the replacement of the Databases and Operative Systems
- Responsible for the document review on periodic basis.
- Responsible for the GxP and Data integrity assessment.
- Responsible for the implementation of Real time release testing.
Compliance Analysis (Update\Creation)
User Requirement (Update\Creation)
Functional Specification (Update\Creation)
Application Risk Assessment (Update\Creation)
Traceability Matrix Creation (Update\Creation)
Test Protocol Issue
Data Migration Protocol Issue - Responsible for the Quality compliance, investigation and CAPA.
- Validation of the computer system performing a GAMP5 V cycle including control system validation and CFR Part 11/Data Integrity compliance verification, focusing on clear definition of regulatory requirement and regulated electronic records.
- Knowledge of Software development lifecycle model and validation practices
Sr, Consultant
Qforce pharma LLP Consulting
Pune
11.2021 - 04.2022
- Responsible for review of CRQ change request in Service now. Responsible for review of test strategy & test cases according to test plan
- End to end validation activities for IT projects and system releases
- Responsible for coordination of stakeholders to review & approve the computer system validation documents.
- To review the CSV data in Docusign.
- Review of all computerized system validation data during & after completion of activity.
- Gap assessment of computerized system.
- Analyze the risk & mitigate the plan accordingly
- Responsible for take the approval from stake holders relevant to CSV deliverables.
- Review & approve IT360 data.
- Review the CMMS Documents.
- Responsible for review of CAPA, Incidents, RCA & Deviation
- Well versed knowledge about GxP, GAMP5 & Latest GAMP 5.2, USP1058, 21 CFR Part11, Annex11, ISO 27001 and ISO 17025
- Responsible for support to customer on regulatory audits like-USFDA, MHRA, and NABL
Manager
Efrac
Kolkata
03.2021 - 11.2021
- Responsible for overall function of Quality system.
- To track the CAPA & give presentation on Quality review meeting.
- Responsible for pharmacopeia updates & inform to concern department.
- To design Custom Calculation Templates in Open lab and Chromeleon Software.
- To review Instrument, Equipment and Software Qualification Documents.
- To review Incidences, deviation, Change Control and OOS.
- To review and approve control documents viz. - SOP, GTP, Specifications, STP while complying with Pharmacopoeia and Regulatory requirements.
- Approval of pre analytical errors & provide training to employees related to data integrity.
- To review and approve the test results & data electronically and ensuring compliance to GXP for critical Computerized System (GDP, GLP&GCP)
- Responsible for Internal audit, external audit & regulatory.
- Get the approval from regulatory agencies also filled the application for renewal of NABL accreditation.
- Gap assessment of computerized system
Compliance Consultant
IQVIA, kelly
Pune
09.2019 - 03.2021
- Responsible for execution of LIMS Labware validation activities.
- Responsible for coordination of stakeholders to execute the computer system validation.
- To prepare Validation Master Plan, Regulatory risk assessment, Electronic data compliance User requirement specification, Functional risk specification, Functional risk acceptance, Configuration specification, Installation qualification protocol, Operational qualification protocol, Performance qualification protocol, Traceability matrix, Validation Summary Report & System release certificate.
- To review and approve the test results & data eelectronically and ensuring compliance to GXP for critical Computerized System (GDP, GLP&GCP)
- Review of all computerized system validation data during & after completion of activity.
- Software validation of all Production, Quality control & R&D department. Like LIMS Labware 7, Open lab, Chromeleon, opus, Lab solution, Labx, AFL, Stability 1.3, Stability 7.4T, Malvern, UV probe, Lab view, Pyrus & many more.
- Gap assessment of computerized system
- Effectively and accurately communicate relevant project information to the end users.
- Analyze the risk & mitigate the plan accordingly.
Analytical Quality Assurance
Choksi Laboratories Limited
Indore
01.2016 - 09.2019
- Responsible for review of Laboratories Audit Trials on Periodic basis. Instrument like Balance, HPLC,GC, LCMS AAS,FTIR, DSC etc.
- Responsible for review of generated Certificate of Analysis (COA).
- To ensure data integrity compliances at laboratories also responsible for internal audit as QA.
- Responsible for Preparation of URS and Evaluation of Risk Assessment.
- To review Validation Master Plan, Performance Qualification Plan, Validation Summary Report.
- To review and approve the test results & data electronically and ensuring compliance to GXP for critical Computerized System.
- To impart training to concern person.
- To track the CAPA & give presentation on Quality review meeting.
- Responsible for pharmacopeia updates & inform to concern department.
- To design Custom Calculation Templates in Open lab and Chromeleon Software.
- To review Instrument, Equipment and Software Qualification Documents.
- To review Incidences, deviation, Change Control and OOS.
- To review and approve control documents viz. - SOP, GTP, Specifications, STP while complying with Pharmacopoeia and Regulatory requirements.
- Approval of pre analytical errors & provide training to employees related to data integrity.
Executive
Alembic Pharmaceuticals Vadodara, G.J
12.2014 - 05.2015
- Analysis of inprocess, finish & stability product.
- Instrument handling like HPLC, GC, UV, IR, Dissolution Tester, KF & Autotitrator Apparatus, pH & Conductivity Meter, Disintegration and Friability Apparatus. Ensure that all the activities and records are completed and reviewed in accordance with established SOPs and cGMP regulation.
- Ensure calibration and Qualification of Equipment’s as per set frequency.
- Faced all regulatory/non-regulatory audits.
Executive
lpca Laboratories
Vadodara
11.2013 - 12.2014
- Analysis of inprocess, finish & stability product.
- Instrument handling like HPLC, GC, UV, IR, Dissolution Tester, KF & Autotitrator Apparatus, pH & Conductivity Meter, Disintegration and Friability Apparatus.
- Ensure that all the activities and records are completed and reviewed in accordance with established SOPs and cGMP regulation.
- To ensure calibration and Qualification of Equipment’s as per set frequency.
- Faced all regulatory/non-regulatory audits.
Executive
Lupin Ltd
Indore
11.2011 - 04.2013
- Analysis of inprocess, finish & stability product.
- Instrument handling like HPLC, GC, UV, IR, Dissolution Tester, KF & Autotitrator Apparatus, pH & Conductivity Meter, Disintegration and Friability Apparatus. Ensure that all the activities and records are completed and reviewed in accordance with established SOPs and cGMP regulation.
- Ensure calibration and Qualification of Equipment’s as per set frequency.
- Faced all regulatory/non-regulatory audits.
Education
Master of Science - Pharmaceutical Engineering
RGPV
Indore 08.2008 - 04.2010
Bachelor of Science - Pharmacy
RGPV
Bhopal 08.2004 - 07.2008
High School Diploma -
M.P. Board
MLB 05.2003 - 08.2004
No Degree - All
M.P. Board
Narsinghpur 04.2001 -
Skills
Vendor Audit Performedundefined
Accomplishments
- Certified by Udemy on Quality risk management on March 2022 (ISO 9001:2015)
- Certified by QCI on ISO /IEC 17025:2017 General requirement for (Laboratory Quality system &
- Certified by QCI (Internal Audit) the competence of testing and calibration laboratories on July 2021
- JIRA software live app Certified by Udemy (ISO 9001:2015)
- Certified by MP State pharmacy council as Registered Pharmacist (Pharmacy act 1948)
- Participated in Computer system validation conference, during 19th-20th Januray 2019
- REGULATORY AUDIT, CUSTOMER AUDIT and VENDOR AUDITS
- REGULATORY AUDITS FACED
- USFDA audit as front auditee to USFDA Auditor
- CDSCO Audit
- State FDA Audits
- NABL (ISO 17025:2005 Quality System) Audits for Testing and Calibration.
Timeline
Sr.CSV Consultant
PQE Group
06.2022 - Current
Sr, Consultant
Qforce pharma LLP Consulting
11.2021 - 04.2022
Manager
Efrac
03.2021 - 11.2021
Compliance Consultant
IQVIA, kelly
09.2019 - 03.2021
Analytical Quality Assurance
Choksi Laboratories Limited
01.2016 - 09.2019
Executive
Alembic Pharmaceuticals Vadodara, G.J
12.2014 - 05.2015
Executive
lpca Laboratories
11.2013 - 12.2014
Executive
Lupin Ltd
11.2011 - 04.2013
Master of Science - Pharmaceutical Engineering
RGPV
08.2008 - 04.2010
Bachelor of Science - Pharmacy
RGPV
08.2004 - 07.2008
High School Diploma -
M.P. Board
05.2003 - 08.2004
No Degree - All
M.P. Board
04.2001 -
Similar Profiles
Danrley M. F. LimaDanrley M. F. Lima
CSV Consultant at PQE GroupCSV Consultant at PQE Group
Animesh BanerjeeAnimesh Banerjee
Operation Team Leader at PQE GroupOperation Team Leader at PQE Group
Rajasree BhattacharjeeRajasree Bhattacharjee
Talent Acquisition Specialist at Pharma Quality Europe (PQE) GroupTalent Acquisition Specialist at Pharma Quality Europe (PQE) Group