LMS
Sachin Kumbhar
CSV And Project Engineer
Pune,Maharshtra
Summary
6 years of experience in pharmaceuticals/life science industry in Computer System Validation, Quality Engineering, Quality Management System, maintenance and troubleshooting,, qualification, documentation review, audit compliance and Automation at regulatory approved facilities.
(Well versed with cGMP, GDP, 21CFR 210 & 211, ISPE, ICH, PIC/S, GAMP5, 21 CFR part
11, EU annex 11, Calibration Management, EN285, ISO standards, WHO guidelines)
Overview
7
7
years of professional experience
Work History
QMS Officer
Gennova Biopharmaceutical Ltd
06.2022 - Current
- · Quality Management System: Handling of QMS documentation such as Change control, Planned Deviation, Unplanned deviations, CAPA, effectiveness monitoring, quality risk assessment.
- · Computer System Validation - Preparation, review and execution of CSV deliverables like SIA, URS, VA,PVP, FS, DQ,IQ, OQ, PQ,RTM,VSR Computer System Risk Assessment, Periodic Review Report, SOP with sound knowledge of 21 CFR part 11, GAMP 5, EU annex 11 requirements.
- · Author, review and approve of CSV Protocols and reports for periodic re-qualification of existing software.
- · Exposure to GDP, GMP, FMEA, GAMP-5, Software Categorization.
- · Exposure to Internal Audits, Customer Audits which includes preparation for audit, providing timely effective response
- · Have thorough understanding and practical approach for Computer System Validation.
- · Having exposure to work on Preventive Maintenance, Calibration as well as Breakdown maintenance and spare management.
- · Participation in FAT, SAT, IOQ and PQ activities for execution of protocols, handling deviations occurred during qualification etc.
- · Perform gap analysis, Risk Assessment using FMEA model, implement Quality Risk Management Systems to define validation strategy.
Officer- Engineering
Indoco Remedies Pvt Ltd.
03.2022 - 05.2022
- · (BMS) Qualification and take partition in installation/ operational qualification to verify BMS and HVAC related test execution, to verify alarms, interlocks, logic level and appropriate functioning of software and automated equipment, systems.
- · Preparation and review of qualification deliverables like URS, DQ, IQ, OQ, PQ protocols for engineering utilities equipment’s.
- · Author, review and approve of SOP’s related to Equipment Qualification, Computerized System Validation.
Senior Officer
Glenmark Pharmaceutical Ltd
07.2020 - 03.2022
- •Ensures timely & effective operation & maintenance of all utility equipments, water, steam & HVAC systems
- •Handling Routine HVAC Qualification
- •Author, review and approve of CSV deliverable such as Validation Project Plan, RA, URS, FRS, VA, RTM, IQ, OQ, PQ, Periodic Review Report, SOP etc.
- •Experienced of GMP regulatory audits for pharma plant USFDA.
- • Knowledge of considering time constraints like safety, cost and environmental issues.
Junior Engineer
Cipla Pharmaceutical Ltd
06.2017 - 07.2020
- · Automation system: (BMS) Qualification and take partition in installation/ operational qualification to verify BMS and HVAC related test execution, to verify alarms, interlocks, logic level and appropriate functioning of software and automated equipment.
- · Preparation and review of qualification deliverables like URS, DQ, IQ, OQ, PQ protocols for engineering utilities equipment’s.
- ·Electrical and HVAC Maintenance:
- See whole area activities including troubleshooting,maintenance and operation of:
- AHUs, Chillers,Scrubbers,PHE,Diesel Generators,Dehumidifiers,Water System,Autoclave,
- LYO,Walk in chamber and Deep freezers.
Education
Bachelor of Engineering - Electrical Engineering
SGM College Of Engineering
Mahagaon 04.2001 -
Diploma in Engineering - Electronics And Telecommunication Engg.
Dr. A. D. Shinde Institute Of Technology
Bhadgaon 04.2001 -
S.S.C -
New English School
Mugali 04.2001 -
Skills
CSV
Software
SAP-MM
BMS-EBI (V500& 600) Honeywell
MS Office
SAP-QM
Timeline
QMS Officer
Gennova Biopharmaceutical Ltd
06.2022 - Current
Officer- Engineering
Indoco Remedies Pvt Ltd.
03.2022 - 05.2022
Senior Officer
Glenmark Pharmaceutical Ltd
07.2020 - 03.2022
Junior Engineer
Cipla Pharmaceutical Ltd
06.2017 - 07.2020
Bachelor of Engineering - Electrical Engineering
SGM College Of Engineering
04.2001 -
Diploma in Engineering - Electronics And Telecommunication Engg.
Dr. A. D. Shinde Institute Of Technology
04.2001 -
S.S.C -
New English School
04.2001 -
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