Goutam Debnath
Agartala
Summary
To work in a competitive environment with sincerity, dedication, responsibilities and challenge to prove myself in the exploring science world with zeal to learn by scientific attitude. Streamlining the activities, encourage new ideas; focus on new projects in multi-disciplinary group to achieve the organizational goals and objectives.
Over 15 years of experience in Pharmaceutical with Software Development Life Cycle, 21 CFR Part-11 Validation, Change Control, Management testing, Defect management and implementation of business applications
Overview
15
15
years of professional experience
Work History
Sr. SPECIALIST IT QUALITY AND COMPLIANCE
BAXTER
Bangalore
08.2019 - Current
- Handling of HPALM Tool for Release, Requirements, Testing and Defect management.
- Handling of TcU for Good Documentation Management.
- Handling of BMC Remedy for IT Change control Management.
- Experience in Preparation and reviewing of all SDLC documents, protocols and SOP's to ensure they meet GxP and FDA regulations.
- Experience in IT Infrastructure Qualification.
- Ensure system qualification/validation documentation is in compliance with Client policies and procedures, as well as meet regulatory requirements.
- Responsible for creation, execution and review of validation packages as per Clients requirements.
- Ensure System Backup and System Audit Trail Verification tests are conducted as per client’s guidelines and FDA regulations.
- Involved in CSI/DI Remediation plan (computer system integrity / Data integrity) in all plants doing Assessment and Remediation plan.
- Handling of internal audit for computerized system.
SR. TEST LEADER LEAD
KPIT TECHNOLOGY LTD.
Bangalore
06.2018 - 07.2019
- Handling of HPALM Tool for Release, Requirements, Testing and Defect management.
- Handling of TcU for Good Documentation Management.
- Handling of BMC Remedy for IT Change control Management.
- Experience in Preparation and reviewing of all SDLC documents, protocols and SOP's to ensure they meet GxP and FDA regulations.
- Experience in IT Infrastructure Qualification.
- Ensure system qualification/validation documentation is in compliance with Client policies and procedures, as well as meet regulatory requirements.
- Responsible for creation, execution and review of validation packages as per Clients requirements.
- Ensure System Backup and System Audit Trail Verification tests are conducted as per client’s guidelines and FDA regulations.
- Handling of Project: BaxLIMS COA Formatting Application, BaxLims Trending, Ahmedabad CSI Remediation, SAP Ahmedabad Application, AIP-Application Integration Platform vNext Cloud, Batch Release System, ECM Account Creation, EVOIQ Traffic Simulator, Compliance Builder Software, Laboratory Software Validation in Syngene, Infrastructure Qualification in BRD01 and BRD02, Versia APAC.
- Client Details: Baxter Innovations and Business Solutions Pvt. Ltd.
SR. PROJECT VALIDATION SPECIALIST
IVY WOORKS ADVISOR
Bangalore
11.2015 - 05.2018
- Compliance and Computer System validation.
- PLC, HMI, SCADA based Equipment validation.
- Handling of Client Project And Job Description.
- Clients Details: Sun Pharmaceuticals Ltd, Strides Shasun, Alembic, Tenshi.
- Computer system validation deliverables and execution of test cases.
- Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report.
- Knowledge about MES software developing and validation deliverables.
- Experience in reviewing all SDLC documents, protocols and SOP's to ensure they meet GxP and FDA regulations.
- Experience in Developing and reviewing User Requirement Specifications URS, Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents.
- Working knowledge of GLP, GCP, GMP, GAMP V guidelines especially in the areas of computer or related systems.
- Review of documents (IRA,URS, VP, TP, FRS,DRS,FRA,IQ,OQ,PQ ,RTM, change control and deviation).
- Execution of IQ, OQ and PQ test cases.
- Preparation of validation deliverables like VP, IRA,URS, DS or CS,TP, FRS,FRA,IQ,OQ,PQ ,RTM and VSR.
- Computer system validation in laboratory System and manufacturing area.
- IT infrastructure qualification, software validation and Compliance 21 CFR part 11.
- Reviewed and Validated Computer Systems in compliance with 21 CFR Part 11 and GxP FDA Regulations.
- Preparation of 21 CFR part 11 checklist.
- Knowledge about IAAS, PAAS and SAAS cloud system.
- Computer System Validation (GAMP5, EU ANNEX11, FDA 21 CFR part 11 and WHO).
- Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems.
- Work under Category 1, Category 3 and Category 4 risk based approach software(CDS and Non CDS).
- Responsible to prepare SOP’s related administrative security policies on software, backup and restoration of electronic data generated by laboratory instrument and equipment software.
- To maintain and secure 21 CFR part 11 compliance of laboratory instrument and equipment software.
- Know about technical, administrative and procedural control on software system.
- Review of control on application, OS, database and network.
- Software validations like LIMS,SAP and EMPOWER and Non CDS system.
- Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve quality.
CQA (QA EXECUTIVE)
ADCOCK INGRAAM HEALTH CARE LTD
Bangalore
01.2015 - 11.2015
- Company Overview: INSPECTED & APPROVED BY VARIOUS REGULATORY AUTHORITIES & GMP CERTIFICATE ISSUED
- INSPECTED & APPROVED BY VARIOUS REGULATORY AUTHORITIES & GMP CERTIFICATE ISSUED
QA EXECUTIVE
MICRO LABS LTD
Bangalore
05.2010 - 09.2014
- Company Overview: INSPECTED & APPROVED BY VARIOUS REGULATORY AUTHORITIES & GMP CERTIFICATE ISSUED
- INSPECTED & APPROVED BY VARIOUS REGULATORY AUTHORITIES & GMP CERTIFICATE ISSUED
Education
B.Pharm -
Karnataka college of pharmacy
D.Pharm -
Achary college of pharmacy
SSLC -
Charipara Junior CollegSecondary Board of Education
PUC -
Hapania High School
Skills
- HPALM tool management
- 21 CFR Part 11 compliance
- Quality assessment
- Continuous improvement
- Risk management
- Root-cause analysis
- Supply management
- Regulatory compliance
- Problem-solving abilities
- Audit reporting
- Cross-functional team leadership
- Computer system validation
- Documentation management
- Good manufacturing practices
- Risk assessment methodology
- IT infrastructure qualification
- Change management processes
Accomplishments
- B.Pharm, Karnataka College of Pharmacy, 12/2009, 2nd year, 71, 3rd year, 72, 4th year, 72
- D.Pharm, Achary College of Pharmacy, 10/2005, 1st year, 69, 2nd year, 74
- SSLC, Charipara Junior College, 09/2003, 42
- PUC, Hapania High School, 07/2001, 51
Hobbies and Interests
- Cricket
- Chess
Disclaimer
I hereby declare that the information provided above is true to the best of my knowledge and belief.
Languages
- Bengali
- Hindi
- English
- Kannada
Personal Information
- Father's Name: Subodh Debnath
- Mother's Name: Sadana Debnath
- Date of Birth: 01/04/85
- Gender: Male
- Nationality: Indian
- Marital Status: Single
Languages
English
Advanced
C1
Hindi
Advanced
C1
Bengali
Proficient
C2
Timeline
Sr. SPECIALIST IT QUALITY AND COMPLIANCE
BAXTER
08.2019 - Current
SR. TEST LEADER LEAD
KPIT TECHNOLOGY LTD.
06.2018 - 07.2019
SR. PROJECT VALIDATION SPECIALIST
IVY WOORKS ADVISOR
11.2015 - 05.2018
CQA (QA EXECUTIVE)
ADCOCK INGRAAM HEALTH CARE LTD
01.2015 - 11.2015
QA EXECUTIVE
MICRO LABS LTD
05.2010 - 09.2014
B.Pharm -
Karnataka college of pharmacy
D.Pharm -
Achary college of pharmacy
SSLC -
Charipara Junior CollegSecondary Board of Education
PUC -
Hapania High School