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
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
- 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.
- Life science validation: There are 4 main types of validation: Prospective Validation, Concurrent Validation, Retrospective Validation, Revalidation (Periodic and After Change)
- Experience in Industrial HMI/Control Systems/SCADA
- Preparation and Execution of PLC, HMI, SCADA based Equipment validation documents for Pharmaceutical client companies as per GAMP5, 21CFR guidelines
- Preparation of validation deliverables like VP, IRA,URS, DS or CS,TP, FRS,FRA,IQ,OQ,PQ ,RTM and VSR.
- Experience in execution of the validation methodology, the application of cGMP (Validation Master Plan, URS, RA, Design Qualification, Installation & Operational Qualification, Performance Qualification and Validation Reports) and specific regulations applicable to the “computer” domain (FDA’s 21 CFR Part 11, Eudralex Annex 11).
- Preparation and review of application of SOPs (Change Control, Incidents Management, Access Management, Backup and Restore.
- Monitor that validation deviations are properly generated, managed and completed.
- Knowledge of good practices in electronic records management
- Knowledge of risk analysis methods applicable to computerized systems (such as FMEA)
- Knowledge of projects and qualification steps, including commissioning.
- GAP Analysis
- Handling of discrepancies.
- Clients Details: Sun Pharmaceuticals Ltd, Strides Shasun, Alembic, Tenshi
CQA (QA Executive)
Adcock Ingraam Health Care Ltd
Bangalore
01.2015 - 11.2015
- Company Overview: Adcock Ingram Health Care Ltd inspected & approved by various regulatory authorities & GMP certificate issued.
- Adcock Ingram Health Care Ltd inspected & approved by various regulatory authorities & GMP certificate issued.
- TGA Australia Approval (Therapeutic goods administration)
- MCC South Africa Approval (Medicines control council)
- WHO Approval (World health organization)
- IDA Netherland Approval (International Development Association)
- IDMA Approval and NDA Approval
QA Executive
Micro Labs Ltd
Bangalore
05.2010 - 09.2014
- Company Overview: Micro Labs inspected & approved by various regulatory authorities & GMP certificate issued.
- Monitoring process steps involving in: Granulation-wet & dry Granulation(Rapid mixer granulator machine), Drying – Fluidised bed drier machine, Filling – AF 90T & AF 150T Filling machine, Compression or tableting - Rimek & SejongTablets compression machine and destiny 8000, Coating - Enteric coating,Film Coating and sugar coating (Neocota,conventional pan & sejong coating machine), Packing blister machine –honga –hanna, elmech ,technofour, Packing Dry syrup machine- dosa dry syrup machine and strip packing
- Monitoring process steps involving in: Washing, Dry zone, Hot zone, Cooling zone process, Filling of Ampoules, Sterilization with Autoclave, Autoclave validation, Labeling and Blister packing
- Handling and review of change control and deviation
- Preparation and review of qualification documents and (protocol and report)
- Preparation and review of validation documents (protocol and report)
- Preparation of standard operating procedure
- Review of external calibration records
- Preparation and review of stability protocol and product quality review.
- Preparation of BMR and BPR
- Preparation of Raw material, finished product specification
- Preparation of Barcode labels
- Risk Assessment
- Micro Labs inspected & approved by various regulatory authorities & GMP certificate issued.
- UK MHRA Approval (Medicines and healthcare products regulatory agency)
- TGA Australia Approval (Therapeutic goods administration)
- Health Canada Approval
- MCC South Africa Approval (Medicines control council)
- WHO Approval (World health organization)
- IDA Netherland Approval (International Development Association)
- IDMA Approval and NDA Approval
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
- IT change control
- SDLC document review
- Computer system validation
- GxP compliance
- Risk assessment
- Project management
- Quality assurance
- Regulatory documentation
- Process optimization
- Effective communication
- Problem solving
- Team collaboration
- Time management
- Proficient in ServiceNow, HPALM, Reliance, Teamcenter, Remedy change management Tool
- Quality assessment
- Risk management
- Root-cause analysis
- Supply management
- Compliance monitoring
- Documentation management
- Vendor management
- Regulatory compliance
Accomplishments
- B.Pharm, Karnataka College of Pharmacy, 12/01/09, 71%, 72%, 72%
- D.Pharm, Achary College of Pharmacy, 10/01/05, 69%, 74%
- SSLC, Charipara Junior College, 09/01/03, 42%
- PUC, Hapania High School, 07/01/01, 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
Bengali, English, Hindi
First Language
Timeline
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