Kirankumar Jeerankalagi
Summary
Qualified engineer with professional experience in Computer System Validation, equipment validation and Quality Engineering for Pharmaceutical/Life Science. I've been working in the equipment, systems, and software for about a decade. I ensured that controls put in place so that equipment, software, and systems are validated, documented, and perform as expected/designed; throughout the life cycle. A Computerized System Validation expert with a proven history of demonstrating leadership, communication, and decision-making talents.
Overview
12
12
years of professional experience
4
4
Languages
Work History
Senior Quality Specialist – Quality Assurance
SDC Clinical (India) Private Limited
- Computer system validation activities for equipment in accordance with GAMP 5, 21 CFR Part 11, EU Annexure 11 and GxP compliance in pharmaceutical industry.
- Validation of critical GxP system by performing Gap Assessment and Risk Assessments.
- Authoring / reviewing documentation throughout Computer System Validation life cycle like Validation Master Plan (VMP), User Requirement Specification, Design Specification, Test scripts, Test cases, Validation Summary Report (VSR), ERES and ERAT, Traceability matrix and SOPs.
- Preparation of URS, Traceability matrix, Validation protocol and validation summary report.
- Significant experience in authoring / reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Requirement Traceability Matrices (RTM)
- Experience in qualification and release of new projects related to process equipment, utilities, and facility including preparation, review and execution of protocol and reports, SOPs as and when required.
- Basic knowledge of TFM document review
- Conducts internal and external (supplier) audits as needed
- Manages the supplier qualification program; ensures compliance with current process, and suggests improvements to the program as needed.
- Serves as the QA lead on validation projects, which includes providing validation guidance to teams as well as reviewing and approving all validation documentation (Validation Plans, Specifications, Executed Scripts, Validation Summary Reports, Change Controls).
- Hand on experience in ZenQMS
- Validation experience in iMednet, Medidata, Veeva Vault, Customized softwares (SDC capture and SDC insights).
Assistant Manager
Biocon Biologics Limited
04.2022 - 08.2024
- Computer system validation activities for equipment in accordance with GAMP 5, 21 CFR Part 11, EU Annexure 11 and GxP compliance in pharmaceutical industry.
- Validation of critical GxP system by performing Gap Assessment and Risk Assessments.
- Authoring / reviewing documentation throughout Computer System Validation life cycle like Validation Master Plan (VMP), User Requirement Specification, Design Specification, Test scripts, Test cases, Validation Summary Report (VSR), ERES and ERAT, Traceability matrix and SOPs.
- Preparation of URS, Traceability matrix, Validation protocol and validation summary report.
- Significant experience in authoring / reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Requirement Traceability Matrices (RTM)
- Review and approval of qualification document through eVLMS
- Experience in qualification and release of new projects related to process equipment, utilities, and facility including preparation, review and execution of protocol and reports, SOPs as and when required.
- Experience in Change Management, Deviation, CAPA management using Trackwise and Involved in regulatory audits viz: USFDA, TGA, WHO, MHRA, ANVISA etc.
- Experience in qualification and release of new projects related to process equipment, utilities, and facility including preparation, review and execution of protocol and reports, SOPs as and when required.
Senior Executive
Mylan Laboratories
10.2017 - 04.2022
- Computer system validation activities for IT systems & equipment in accordance with GAMP 5, 21 CFR Part 11, EU Annexure 11 and GxP compliance in pharmaceutical industry.
- Authoring / reviewing documentation throughout Computer System Validation life cycle like Validation Master Plan (VMP), User Requirement Specification, Design Specification, Test scripts, Test cases, Validation Summary Report (VSR), ERES and ERAT, Traceability matrix and SOPs.
- Implementation and validation of PLC/SCADA based on GAMP5.
- Experience in authoring / reviewing Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Traceability Matrices (TM).
- Experience in validating and release of Equipment software with their interface like SCADA / IPC.
- Well versed with Software Development Life Cycle (SDLC) and experience in the V-Model Software Development.
- Significant experience in Gathering/Eliciting user requirements to create functional design documents and Acceptance Criteria.
- Experience in Change Management, Deviation, CAPA management using Trackwise and Involved in regulatory audits viz: USFDA, TGA, WHO, MHRA, ANVISA etc.
- Operation & Maintenance: Specialized Pharmaceutical Machinery with Aseptic Processing like vial washing, tunnel, filling, autoclave and lyophilizer.
- Perform Root cause investigation by using tools (FMEA, Fault tree analysis & 5 WHY) and propose CAPA (Corrective action and Preventive action) to avoid re-occurrence.
- Team building skills with ability to balance and work with a variety of internal and external stakeholders.
- Have hands on experience in using electronic document management (DCM) used for review and approval of document electronically.
Senior Associate
Syngene International Limited
04.2016 - 10.2017
- Computer system validation activities for IT systems & equipment in accordance with GAMP 5, 21 CFR Part 11, EU Annexure 11 and GxP compliance in pharmaceutical industry.
- Validation of critical GxP system by performing Gap Assessment and Risk Assessments.
- Authoring / reviewing documentation throughout Computer System Validation life cycle like Validation Master Plan (VMP), User Requirement Specification, Design Specification, Test scripts, Test cases, Validation Summary Report (VSR), ERES and ERAT, Traceability matrix and SOPs.
- Implementation and validation of PLC/SCADA based on GAMP5.
- To work on regulatory commitment projects and ensure the same are completed within stipulated time.
- To remediate on Engineering activities / practices being followed.
- Coordination with Cross Functional Teams (CFTs) to perform maintenance activities during shut down.
- Responsible for planning, commissioning of new equipment's.
- To perform Gap assessment of Procedures/Practices being followed.
- To work on Mechanical/ Utility related projects (Water system) and have technical discussions with vendors.
- Coordinating with production block in-charge for meeting their day-to-day Requirements.
- Executing CAPAs, Initiating and executing Change Controls.
Kemwell Biopharma
12.2012 - 04.2016
- Preparation project planning sheet and Coordination with Vendors about work executions, completion of allotted works within the timeline
- Preparation and execution of equipment qualification (IQ and OQ)
- Handling of documentation, QMS and CMS systems for engineering department.
- Preparation and modification of AutoCAD drawings for Mechanical & Civil related Drawings, facility related drawings.
Education
Mechanical Engineering
GVIT
India06-2011
Diploma -
Govt. Polytechnic Belagavi
India06-2006
S.S.L.C -
SSM School
India06-2003
Skills
Knowledge of GDP, GxP, cGMP, and Data Integrity (ALCOA)
Areas of expertise
Computerized System Validation, Equipment validation, Quality Management System, Risk Management, Gap Assessment and RCA
Industries
- Life Science Domain
- Pharma
Timeline
Assistant Manager
Biocon Biologics Limited
04.2022 - 08.2024
Senior Executive
Mylan Laboratories
10.2017 - 04.2022
Senior Associate
Syngene International Limited
04.2016 - 10.2017
Kemwell Biopharma
12.2012 - 04.2016
Senior Quality Specialist – Quality Assurance
SDC Clinical (India) Private Limited
Mechanical Engineering
GVIT
Diploma -
Govt. Polytechnic Belagavi
S.S.L.C -
SSM School