Chirag G Patel
Computer System Validation Engineer
Ahmedabad
Summary
- Have more than 8.2 years of overall experience in Computerized System Validation of Enterprise Computerized systems, Standalone Computerized systems, Process control systems, Laboratory Computerized systems, Excel worksheets, etc.
- Sound knowledge of GxP system, Predicate Rules, GAMP 5, EU Annex 11 and USFDA 21 CFR Part 11, 210 and 211, ICH Q9 risk assessment, data integrity, ALCOA +, etc.
- As a subject matter expert in compliance, IT and CSV, participate in internal, regulatory (such as FDA, MHRA, EU, WHO, Health Canada, etc.) and customer audits
- Expertise in Preparation and Execution of BMS, DAS, laboratory Equipment’s and Camera System and packing Track and Trace systems.
- Experts in IT-related policies and procedure, such as user access management, electronic data backup and restoration, disaster recovery, server management, data archival, adequate control of computers and related systems, vendor management, etc..
Overview
8
8
years of professional experience
18
18
years of post-secondary education
Work History
Computer System Validation (Assistant Manager)
Zydus Lifesciences Limited, Moraiya, Ahmedabad
Ahmedabad, Gujarat
07.2019 - Current
- Team leader for all CSV-IT related task.
- Execution and preparation of computer system validation all deliverables and scripts
- Handling of User management activity,Desktop Policy,Backup and restoration of GxP Equipment’s
- Prepare and maintain IT related SOP and policy in Documentam.
- Initiate CAPA, change control and Deviation in Trackwise for IT related task.
- Prepare presentation on planning and Timeline in monthly review Meeting for new Projects
- Represent the IT related activity in regulatory Audit
Senior Technical Supervisor in QA IT
Cadila Pharmaceuticals Limited, Dholka Plant
Ahmedabad, Gujarat
06.2018 - 05.2019
- Preparation of SOP related with Computer System, reviewing Corporate related SOPs and conducting training to individuals.
- For new instruments/ Equipment's Software Qualification protocol preparation and execution as per CSVMP (COMPUTER SYSTEM VALIDATION MASTER PLAN) to maintain the guidelines of 21 CFR Part 11
- Performing periodic review of Lab system Software’s and Manufacturing equipment’s Software's to maintain the validation activity of the system.
- Handling of User management activity and data backup and restoration of Lab software as well as desktop policy in Lab PC.
- Maintain the Inventory list of Computerized System and QMS activity for Manufacturing and QC.
- Perform back up and restoration procedure for QC and Manufacturing equipment
- Finding GAP assessments in Software Qualifications and according to it preparation and execution of qualification protocol
- Performing Vendor Assessments for new vendor.
CSV Validation Asst. Engineer (Team Leader)
Kevin Technologies Pvt. Ltd
Ahmedabad, Gujarat
04.2015 - 06.2018
- Provide Regulatory Compliances as per GAMP5 and 21 CFR Part11.
- Coordinating with the Higher Authorities at the site location as a Team Leader and Carrying out Onsite Validation activity.
- Document cycle prepare (i.e. IRA,URS ,VP,FDS,FRA,CS,IQ,OQ,PQ RTM, VSR,etc).
- Functional checking of Software system, checks I/O by simulation, troubleshooting of different types of pharmaceutical machines.
- Manufacturing and Laboratory Software Validation, BMS, Water System, Camera System validation and handling in different project sites as team member and team leader
Education
B.Tech - Electronics And Communication,
Charotar University of Science And Technologies
AT-Changa, Dist:-Nadiad, Gujarat, 06.2011 - 06.2014
Diploma, - Electronics And Communication,
Gujarat Technological University
Kheda, Gujarat, 03.2008 - 06.2011
H.S.C , - Science Education. ,
GHSEB
Bavla, Gujarat, 03.2006 - 03.2008
S.S.C - Education
GSEB
Bavla, Gujarat, 06.1996 - 03.2006
Skills
CSV Compliance IT Manufacturing Automation QA IT QMS
Accomplishments
- Successfully implement and validated Paper Less User management activity in ZyUAMS (Zydus User Access Management) Software for manufacturing User management.
- Implement Backup and Restoration procedure in Manufacturing equipment’s.
- Implement Desktop Policy in all manufacturing Equipment’s
- Successfully completed FDA audit with zero 483 observation,
- Get promoted from Sr. executive to Asst. manager post within 2.10 year.
- Maintain User management activity for all GxP equipment in Dholka Plant
- Review Daily back up and Restoration process for data verification
- Prepare and execute Computer system validation scripts for execution of manufacturing and QC.
- Perform plant periodic review for all legacy system and based on that prepared action plan for CSV validation
- Implement Desktop policy in Manufacturing and QC equipment’s.
- Face different regulatory audit for QA-IT compliance
Key Achievements For Zydus Lifesciences Limited, Moraiya :
Key Achievements Cadila Pharmaceuticals Limited:-
Key Achievements Kevin Technologies Pvt. Ltd :
Successfully Completed Validation Projects of Following Pharmaceutical Companies:
1. Sun Pharmaceutical Industries Ltd.,Halol
2. Lupin Limited,Tarapur
3. Cadila Healthcare Limited, Oncology Plant , Pharmez,Ahmedabad
4. Intas Biopharma Ltd,Moraiya-Ahmedabad
5. Torrent Pharmaceautical – Indrad,Ahmedabad
6. Hospira Healthcare India Pvt. Ltd (Pfizer),Ahmedabad
7. Intas Pharmaceuticals Ltd.,Ahmedabad
8. Glenmark Pharmaceuticals Ltd.,Goa
9. Zydus Technologies Ltd.,Ahmedabad
10. Cadila Helthacre Limited, Ankleshwar (Unit 1 & Unit2)
11. Marksans Pharma,Goa
12. Watson Pharma,Goa
Personal Details
Date of Birth :-29/08/91
Gender - Male
Nationality -Indian
Marital Status – Married
Hobbies - Listening to Music, To Visit New Places, Cricket
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Computer System Validation (Assistant Manager)
Zydus Lifesciences Limited, Moraiya, Ahmedabad
07.2019 - Current
Senior Technical Supervisor in QA IT
Cadila Pharmaceuticals Limited, Dholka Plant
06.2018 - 05.2019
CSV Validation Asst. Engineer (Team Leader)
Kevin Technologies Pvt. Ltd
04.2015 - 06.2018
B.Tech - Electronics And Communication,
Charotar University of Science And Technologies
06.2011 - 06.2014
Diploma, - Electronics And Communication,
Gujarat Technological University
03.2008 - 06.2011
H.S.C , - Science Education. ,
GHSEB
03.2006 - 03.2008
S.S.C - Education
GSEB
06.1996 - 03.2006
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